Hepatitis C, ChronicNCT00724230
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 505 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.
Who may be able to join
- Patients diagnosed with chronic hepatitis C
- Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
- Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
Who cannot join
- Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
- Interferon-naïve patients with low viral load
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- Patients with a history of hypersensitivity to biological products, such as vaccines
- Patients being treated with Shosaikoto
- Patients with autoimmune hepatitis
Show all 14Show fewer
- Pregnant women, women who may be pregnant, and nursing mothers
- Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
- Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
- Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
- Patients with chronic renal failure or renal function disorder with creatinine clearance of <=50 mL/min
- Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
- Patients with serious hepatic dysfunction
- Patients with autoimmune hepatitis
About this study
Official title: PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- 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.
PegIntron (peginterferon alfa-2b; SCH 54031)Drug
Also called SCH 54031
PegIntron administered in accordance with approved labeling
Subcutaneous injection once weekly for 24 weeks.
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Overall study population. Receives: Drug: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of adverse events and adverse drug reactions.
Measured: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients
Measured: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
Measured: Assessed at 24 weeks post-treatment
Secondary outcomes (1)
Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.
Measured: End of treatment and 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Time perspective
- Prospective
- Enrolment
- 505 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
- NCT00724230
- Sponsor's protocol ID
- P04841
- Status last verified
- Feb 2015
- First submitted
- 25 Jul 2008
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-
- ClinicalTrials.gov ID
- NCT00724230
- Acronym / sponsor ID
- P04841
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Drug: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)Overall study population. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.
Key inclusion criteria (3 listed)
- Patients diagnosed with chronic hepatitis C
- Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
- Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
Key exclusion criteria (14 listed)
- Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
- Interferon-naïve patients with low viral load
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- Patients with a history of hypersensitivity to biological products, such as vaccines
- Patients being treated with Shosaikoto
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: SCH 54031PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks. | Drug | Arm 1 |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks. | Drug | Arm 1 |
Primary outcome
Overall incidence of adverse events and adverse drug reactions.
Time frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients
Time frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study
Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics
Time frame: Assessed at 24 weeks post-treatment
1 secondary outcome
Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.
Time frame: End of treatment and 24 weeks after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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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 3 inclusion and 14 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 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall incidence of adverse events and adverse drug reactions. (time frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study). The study lists 3 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 3 Feb 2015.