Status:
TERMINATED
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 Viru...
Eligibility Criteria
Inclusion
- 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®
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00423800
Start Date
December 1 2006
End Date
October 1 2009
Last Update
April 7 2017
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