Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
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Purpose
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 Mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12 |
- Number of Participants With a Sustained Virologic Response [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR). If the HCV-RNA is not detectable, the participant is negative for HCV-RNA.
Sustained virologic responders were participants negative for HCV-RNA at 24 weeks following the completion of therapy. A Participant that withdrew prior to 24 weeks following the completion of therapy was considered a non-responder.
- Number of Participants With a Virological Relapse [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
Participants were tested for the presence of Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) in blood by Qualitative Polymerase Chain Reaction (qPCR).
Virological relapse in participants was defined as having negative virology (HCV-RNA) at end of treatment, but positive virology (HCV-RNA) again at 24 weeks of follow up post treatment.
| Enrollment: | 56 |
| Study Start Date: | December 2006 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pegetron® - 24 Weeks
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 16 weeks of treatment
|
Drug: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Other Names:
|
|
Active Comparator: Pegetron®- 48 Weeks
Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 40 weeks of treatment.
|
Drug: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must demonstrate willingness to participate in the study.
- Diagnosed with chronic HCV.
- Between 18 and 65 years of age of either gender and of any race.
- a. HCV positive, >600,000 IU/mL at baseline AND b. Genotype 1.
- Suitable for treatment with Pegetron® per the Canadian product monograph.
- Investigator has already decided to treat with PEGETRON REDIPEN® 1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.
- HCV-RNA negative at treatment week 4.
- Meet certain minimum laboratory values at the week 4 screening visit.
- Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).
Exclusion Criteria:
- Had previous interferon-based therapy for Chronic Hepatitis C.
- Active Hepatitis B virus (HBV) infection.
- Human Immunodeficiency Virus (HIV) antibody positive.
- Cirrhotic (Stage 4 on Metavir system).
- Uncontrolled history or current severe depression or psychoses.
- Uncontrolled epilepsy.
- Use of illicit drugs.
- History of non-compliance to medical regimens.
- Liver disease other than from chronic hepatitis C.
- Participating in any other clinical study.
- Used any investigational drugs within 30 days of screening.
- Participants weighing < 40 kg or > 125 kg.
- Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00423800 History of Changes |
| Other Study ID Numbers: | P05016 |
| Study First Received: | January 17, 2007 |
| Results First Received: | January 27, 2011 |
| Last Updated: | March 24, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Interferon-alpha Interferon Alfa-2a |
Interferon Alfa-2b Interferons Ribavirin Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013