Study Stopped
The trial was terminated due to change in new standard of therapy during the study period.
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)
START 4
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)
2 other identifiers
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2013
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2015
CompletedResults Posted
Study results publicly available
February 23, 2016
CompletedOctober 25, 2018
September 1, 2018
2.1 years
May 24, 2012
January 26, 2016
September 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Achieving Sustained Virologic Response (SVR)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
At 24 weeks after the completion of therapy (up to 72 weeks)
Study Arms (2)
44 Weeks of PEG-IFN alfa-2b + RBV
EXPERIMENTALParticipants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
20 Weeks of PEG-IFN alfa-2b + RBV
EXPERIMENTALParticipants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Interventions
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
Ribavirin 200 mg capsules administered orally daily based on weight
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This Trial was prematurely terminated due to the availability of more promising treatment for HCV participants and the change in treatment guidelines, which will offer the patient a better treatment opportunity.
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
January 1, 2013
Primary Completion
January 26, 2015
Study Completion
January 26, 2015
Last Updated
October 25, 2018
Results First Posted
February 23, 2016
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf