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)
Primary Purpose
Hepatitis C, Chronic
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-IFN alfa-2b
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
44 Weeks of PEG-IFN alfa-2b + RBV
20 Weeks of PEG-IFN alfa-2b + RBV
Arm Description
Participants achieving RVR at 4 weeks of treatment will receive 44 additional 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.
Outcomes
Primary Outcome Measures
Number of Participants Achieving Sustained Virologic Response (SVR)
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01606800
First Posted
May 24, 2012
Last Updated
September 27, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01606800
Brief Title
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)
Acronym
START 4
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
The trial was terminated due to change in new standard of therapy during the study period.
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
January 26, 2015 (Actual)
Study Completion Date
January 26, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
44 Weeks of PEG-IFN alfa-2b + RBV
Arm Type
Experimental
Arm Description
Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
Arm Title
20 Weeks of PEG-IFN alfa-2b + RBV
Arm Type
Experimental
Arm Description
Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
Intervention Type
Drug
Intervention Name(s)
PEG-IFN alfa-2b
Intervention Description
Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
Ribavirin 200 mg capsules administered orally daily based on weight
Primary Outcome Measure Information:
Title
Number of Participants Achieving Sustained Virologic Response (SVR)
Description
SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
Time Frame
At 24 weeks after the completion of therapy (up to 72 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=8908B-059&kw=8908B-059&tab=access
Learn more about this trial
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)
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