Hepatitis C, ChronicNCT00724893
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIFN-2b and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 2,430 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Aug 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.
Who may be able to join
- Treatment-naïve patients with chronic hepatitis C
- Adults (>18 years of age)
- Prescribed Pegetron Redipen
- Must meet all requirements for treatment with Pegetron Redipen
- Must be able to obtain reimbursement of medication through private or provincial coverage
Who cannot join
- Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
- HIV antibody positive
- Post liver transplant patients
- Any other exclusion criteria as per the product Monograph
About this study
Official title: Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIFN-2b, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegIFN-2bBiological
Also called Pegetron®, Pegylated interferon alfa-2b, PegIntron, SCH 054031
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
RibavirinDrug
Also called SCH 018908
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Participants | Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. Receives: Biological: PegIFN-2b; Drug: Ribavirin | |
| Stage 2 Participants | Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. Receives: Biological: PegIFN-2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 62 weeks
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving SVR (Stage 2)
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Secondary outcomes (48)
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment
Measured: Up to 48 weeks
Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)
Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".
Measured: Up to 62 weeks
Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".
Measured: Up to 62 weeks
The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 62 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).
Measured: Up to 62 weeks
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Viral Load (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Weight (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 72 weeks
Number of Participants Achieving EVR (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: From Week 10 to Week 14
Number of Participants Achieving SVR by EVR Type (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Gender (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Race (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants With End of Treatment (EOT) Response (Stage 1)
EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".
Measured: Up to 48 weeks
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 72 weeks
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Week 12
Relapse Rate by HCV Genotype (Stage 1)
The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 48 weeks
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.
Measured: Up to 48 weeks
Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving RVR by Race (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR by Race (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving SVR by Race (Stage 2)
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).
Measured: Week 4
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).
Measured: Week 12
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).
Measured: Up to 72 weeks
Number of Participants Achieving RVR by Weight (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR by Weight (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving SVR by Weight (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Measured: Week 4
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Measured: Week 12
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.
Measured: Up to 72 weeks
Number of Participants Achieving RVR by Gender (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR by Gender (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving SVR by Gender (Stage 2)
SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Number of Participants Achieving RVR by HIV Status (Stage 2)
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".
Measured: Week 4
Number of Participants Achieving EVR by HIV Status (Stage 2)
EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".
Measured: Week 12
Number of Participants Achieving SVR by HIV Status (Stage 2)
SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)
Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724893
- Sponsor's protocol ID
- P04423
- Other IDs
- MK-4031-267
- Status last verified
- Jul 2015
- First submitted
- 25 Jul 2008
- Last updated
- 14 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program
- ClinicalTrials.gov ID
- NCT00724893
- Acronym / sponsor ID
- P04423
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Participants | – | Biological: PegIFN-2b, Drug: RibavirinParticipants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. |
| Stage 2 Participants | – | Biological: PegIFN-2b, Drug: RibavirinParticipants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.
Key inclusion criteria (5 listed)
- Treatment-naïve patients with chronic hepatitis C
- Adults (>18 years of age)
- Prescribed Pegetron Redipen
- Must meet all requirements for treatment with Pegetron Redipen
- Must be able to obtain reimbursement of medication through private or provincial coverage
Key exclusion criteria (4 listed)
- Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
- HIV antibody positive
- Post liver transplant patients
- Any other exclusion criteria as per the product Monograph
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegIFN-2bAlso: Pegetron®, Pegylated interferon alfa-2b, PegIntron, SCH 054031PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling | Biological | Stage 1 Participants, Stage 2 Participants |
| RibavirinAlso: SCH 018908Ribavirin capsules administered orally. Dosing in accordance with approved labelling. | Drug | Stage 1 Participants, Stage 2 Participants |
Primary outcome
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
Time frame: Up to 72 weeks
This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
Time frame: Up to 62 weeks
This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
Time frame: Up to 72 weeks
This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".
Number of Participants Achieving SVR (Stage 2)
Time frame: Up to 72 weeks
SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".
48 secondary outcomes
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
Time frame: Up to 48 weeks
Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
Time frame: Up to 62 weeks
Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
Time frame: Up to 72 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
Time frame: Up to 62 weeks
The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)
Time frame: Up to 72 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
Time frame: Up to 62 weeks
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
Time frame: Up to 62 weeks
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Viral Load (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Weight (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving EVR (Stage 1)
Time frame: From Week 10 to Week 14
Number of Participants Achieving SVR by EVR Type (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Gender (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Race (Stage 1)
Time frame: Up to 72 weeks
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
Time frame: Up to 72 weeks
Number of Participants With End of Treatment (EOT) Response (Stage 1)
Time frame: Up to 48 weeks
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
Time frame: Up to 72 weeks
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
Time frame: Week 12
Relapse Rate by HCV Genotype (Stage 1)
Time frame: Up to 48 weeks
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
Time frame: Up to 48 weeks
Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR (Stage 2)
Time frame: Week 12
Number of Participants Achieving RVR by Race (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR by Race (Stage 2)
Time frame: Week 12
Number of Participants Achieving SVR by Race (Stage 2)
Time frame: Up to 72 weeks
Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
Time frame: Week 12
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
Time frame: Week 12
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
Time frame: Up to 72 weeks
Number of Participants Achieving RVR by Weight (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR by Weight (Stage 2)
Time frame: Week 12
Number of Participants Achieving SVR by Weight (Stage 2)
Time frame: Up to 72 weeks
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
Time frame: Week 4
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) (time frame: Up to 72 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.