Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
Overview
- Phase
- Phase 4
- Intervention
- ribavirin
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 45
- Primary Endpoint
- Number of Participants Achieving Sustained Virologic Response (SVR)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
Detailed Description
Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is ≥40 kg and ≤120 kg weight
- •Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
- •Previously documented CHC genotype 4 infection
- •Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).
Exclusion Criteria
- •Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
- •Treatment for hepatitis C with any investigational medication
- •Treatment with any investigational drug within 30 days of the screening visit
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •Autoimmune hepatitis or a history of autoimmune disease
- •Hepatic fibrosis score F4
- •Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
- •Autoimmune hepatitis or a history of autoimmune disease
- •Thyroid disease uncontrolled with conventional treatment
- •Epilepsy and/or compromised central nervous system (CNS) function
Arms & Interventions
44 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: ribavirin
44 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: PEG-IFN alfa-2b
20 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: PEG-IFN alfa-2b
20 Weeks of PEG-IFN alfa-2b + RBV
Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention: ribavirin
Outcomes
Primary Outcomes
Number of Participants Achieving Sustained Virologic Response (SVR)
Time Frame: At 24 weeks after the completion of therapy (up to 72 weeks)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.