Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059 AM1) (START 4)
This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01606800
First received: May 24, 2012
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: PEG-IFN alfa-2b Drug: ribivirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Drug Information available for:
Interferon
Ribavirin
Interferon Alfa-2a
Interferon Alfa-2b
Peginterferon Alfa-2b
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants Achieving Sustained Virologic Response (SVR) [ Time Frame: At 24 weeks after the completion of therapy (between Week 48 and Week 72) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 + ribavirin.
|
Drug: PEG-IFN alfa-2b
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
Drug: ribivirin
Ribavarin 200 mg capsules administered orally daily based on weight
|
|
Experimental: 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 + ribavirin.
|
Drug: PEG-IFN alfa-2b
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
Drug: ribivirin
Ribavarin 200 mg capsules administered orally daily based on weight
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01606800 History of Changes |
| Other Study ID Numbers: | 8908B-059 |
| Study First Received: | May 24, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | Egypt: Ministry of Health and Population |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon Alfa-2a Interferon-alpha |
Interferon Alfa-2b Ribavirin Peginterferon alfa-2b Reaferon Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013