Hepatitis C, ChronicPhase 4NCT00202839
Peg-Intron/Ribavirin in G 1 HCV for Non-Extended Versus 24 Week Extended Treatment After 24 Weeks (Study P04144)(COMPLETED)
A Phase 4 study testing PegIntron (peginterferon alfa-2b; SCH 54031) and Ribavirin in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- PegIntron (peginterferon alfa-2b; SCH 54031) and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jul 2008
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry.
- The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria:
- Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males
- Neutrophil count >= 1.5 X10^9/L
- Platelets count >= 100 x 10^9/L
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- Total bilirubin < 1.5 mg/dL
- Serum creatinine within normal limits
- Positive serum HCV-RNA (>= 50 IU (100 copy numbers)/mL)
- Anti-HCV positive
- Available HCV genotype 1
- Liver biopsy performed within 12 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (METAVIR system >=F1).
- Compensated liver disease with the following hematological, biochemical, and serologic criteria at the screening visit:
- Hemoglobin values of >= 9 g/dL
- Neutrophil count >= 0.75 x 10^9/L
- Platelets count >= 50 x 10^9/L
- Prothrombin time (PT) prolong <= 3 sec, International Normalized Ratio (INR) <= 1.2
- Total bilirubin <= 3 mg/dL
- Within normal limits (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met).
- Anti-Human Immunodeficiency Virus (HIV) negative.
- Alpha-fetoprotein (AFP) value within normal limits obtained within 12 months prior to entry. Results above the upper limit of normal but <= 50 ng/mL require both of the following:
- AFP value <= 50 ng/mL obtained within 9 months prior to entry in the study or during the Screening period, and Ultrasound obtained within 9 months prior to entry or in the screening period in the study for evidence of not having hepatocellular carcinoma.
- A urine pregnancy test obtained prior to the initiation of pilot treatment must be negative. Female subjects must not be breast feeding.
- Reconfirmation that sexually-active subjects are practicing acceptable methods of contraception during screening period.
- Complete 24 weeks treatment of the Pilot Treatment Program with Peg-Intron + Ribavirin.
- Must be never treated with interferon for HCV infected hepatitis (treatment naïve) before the Pilot Treatment Program.
- The total amount of Peg-Intron and Ribavirin received during the pilot treatment program must achieve more than 80% of the recommended dosage.
Who cannot join
- Women who are pregnant or nursing.
- Have decompensated cirrhosis.
- History of severe psychiatric disease, especially depression.
- Concurrent malignancies (including hepatocellular carcinoma).
- Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities.
- Prolonged exposure to known hepatotoxins such as alcohol or drugs.
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- History of thyroid disease poorly controlled on prescribed medication.
- Poorly controlled diabetes mellitus.
- Has suspected or confirmed significant hepatic disease from an etiology other than HCV.
- Patients co-infected with hepatitis B and /or human immunodeficiency virus (HIV).
- Severe renal disease or myeloid dysfunction.
- History of organ transplantation other than cornea and hair transplant.
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
- Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
- Allergy to interferon.
About this study
Official title: Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.
Read the detailed description
This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatment Program and complete 24 weeks treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects will sign informed consent prior to the end of the Pilot Treatment Program. After completion of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either study group. Subjects in the 24-Week Treatment arm will be followed-up without study medication for 48 weeks; subjects in the 48-Week Treatment arm will be continuously treated for another 24 weeks and all subjects in the 48-Week Treatment arm will be followed for another 24 weeks after completion of the treatment period. Subjects in both arms will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomization.
- Conditions
- Hepatitis C, Chronic
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031), Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegIntron (peginterferon alfa-2b; SCH 54031)Biological
Also called peginterferon alfa-2b; SCH 54031
Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program
PegIntron (peginterferon alfa-2b; SCH 54031)Biological
Also called peginterferon alfa-2b; SCH 54031
Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program
RibavirinDrug
Also called SCH 18908
200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program
RibavirinDrug
Also called SCH 18908
200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program
| Study group | Role | What they receive |
|---|---|---|
| 24-Week Treatment | Experimental | Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization) Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Ribavirin |
| 48-Week Treatment | Active comparator | Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization) Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy
Measured: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy
Secondary outcomes (1)
The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
Virologic response was defined as undetectable HCV-RNA level in the blood.
Measured: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2008
- Study completionJul 2008
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ding-Shinn Chen, MD, Study chair, Investigational Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202839
- Sponsor's protocol ID
- P04144
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 6 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Sustained Response of Peg-Intron/Ribavirin Combination Therapy in Genotype 1-Infected Hepatitis C Patients for Non-extended Versus 24-week Extended Treatment After 24 Weeks Pilot Treatment in Taiwan
- ClinicalTrials.gov ID
- NCT00202839
- Acronym / sponsor ID
- P04144
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, comparative, multicenter, 48-week study designed to evaluate the efficacy and safety of combination treatment with pegylated interferon and ribavirin in adult subjects with a diagnosis of compensated chronic hepatitis C (hepatitis C virus (HCV)-ribonucleic acid (RNA) positive) (Genotype 1). All subjects will complete 24 weeks of treatment, termed the Pilot Treatment Program, after which all eligible subjects will be randomly assigned to one of two study groups. One group will be followed for an additional 48 weeks without study medication, while the other will be continuously treated for an additional 24 weeks and then followed for another 24 weeks without study medication. Sustained virologic response, defined as undetectable HCV-RNA in serum at the end of the follow-up period, will be measured along with other outcomes.
Detailed description
This is an open-label, randomized, comparative, multicenter study for evaluation of PegIntron/Ribavirin therapy in the efficacy and safety in adult subjects with a diagnosis of compensated chronic hepatitis C (HCV-RNA+) (Genotype 1). This is a 48-week study, for which all subjects should participate in the Pilot Treatment Program and complete 24 weeks treatment. To avoid a treatment gap, subjects who will be screened and eligible subjects will sign informed consent prior to the end of the Pilot Treatment Program. After completion of the Pilot Treatment Program, all eligible subjects will be randomly assigned to either study group. Subjects in the 24-Week Treatment arm will be followed-up without study medication for 48 weeks; subjects in the 48-Week Treatment arm will be continuously treated for another 24 weeks and all subjects in the 48-Week Treatment arm will be followed for another 24 weeks after completion of the treatment period. Subjects in both arms will be evaluated at screening, randomization, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24-Week Treatment | Experimental | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: RibavirinGenotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization) |
| 48-Week Treatment | Active comparator | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: RibavirinGenotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Males and non-pregnant females and aged >= 18 years, subjects who are over 65 years of age must be in generally good health and must be discussed with and approved by the principal investigator prior to entry.
- The laboratory evaluation within 6 months prior to entering the Pilot Treatment Program must meet the following criteria:
- Hemoglobin values of >= 12 g/dL for females and >= 13 g/dL for males
- Neutrophil count >= 1.5 X10^9/L
Key exclusion criteria (15 listed)
- Women who are pregnant or nursing.
- Have decompensated cirrhosis.
- History of severe psychiatric disease, especially depression.
- Concurrent malignancies (including hepatocellular carcinoma).
- Unstable or significant cardiovascular diseases. Subjects with (ECG) showing clinically significant abnormalities.
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 |
|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031)Also: peginterferon alfa-2b; SCH 54031Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program | Biological | 24-Week Treatment |
| PegIntron (peginterferon alfa-2b; SCH 54031)Also: peginterferon alfa-2b; SCH 54031Powder for injection in vial (120 microgram strength), subcutaneous, dose of 1.5 micrograms/kg weekly for 24 weeks during the pilot treatment program followed by 1.2 to 1.5 microgram/kg weekly for 24 weeks during the extended treatment program | Biological | 48-Week Treatment |
| RibavirinAlso: SCH 18908200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program | Drug | 24-Week Treatment |
| RibavirinAlso: SCH 18908200 mg capsules, oral, weight-based dose of 1000 or 1200 mg, daily for for 24 weeks during the pilot treatment program and for 24 weeks during the extended treatment program | Drug | 48-Week Treatment |
Primary outcome
The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR)
Time frame: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy
Sustained virologic response was defined as hepatitis C virus ribonucleic acid [HCV-RNA] levels below assay detection 24 weeks after termination of anti-HCV therapy
1 secondary outcome
The Percentage of Participants Who Achieved a Virologic Response 48 Weeks After Randomization.
Time frame: 48 weeks after randomization (with 24 weeks of treatment immediately before randomization and either 0 or 24 weeks of treatment immediately after randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
Ding-Shinn Chen, MD study chair
Investigational Site
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PegIntron (peginterferon alfa-2b; SCH 54031) and Ribavirin in people with Hepatitis C, Chronic, 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 27 inclusion and 15 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 6 Apr 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2011). 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?
The Percentage of Participants Who Achieved a Sustained Virologic Response (SVR) (time frame: 24 weeks of follow-up after either 24 or 48 weeks of anti-HCV therapy). 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 6 Apr 2017.