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)

• ClinicalTrials.gov Identifier: NCT01606800
• Recruitment Status: Terminated
• First Posted: May 28, 2012
• Results First Posted: February 23, 2016
• Last Update Posted: October 25, 2018
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: May 24, 2012
• First Posted Date: May 28, 2012
• Results First Submitted Date: January 26, 2016
• Results First Posted Date: February 23, 2016
• Last Update Posted Date: October 25, 2018
• Actual Study Start Date: January 1, 2013
• Actual Primary Completion Date: January 26, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2016)

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.

• Original Primary Outcome Measures (submitted: May 24, 2012): Number of Participants Achieving Sustained Virologic Response (SVR) [ Time Frame: At 24 weeks after the completion of therapy (between Week 48 and Week 72) ]
• Change History: Complete list of historical versions of study NCT01606800 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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)
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatitis C, Chronic

Intervention

• Drug: PEG-IFN alfa-2b
  Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
• Drug: ribavirin
  Ribavirin 200 mg capsules administered orally daily based on weight

Study Arms

• 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 + RBV.
  Interventions:

  • Drug: PEG-IFN alfa-2b
  • Drug: ribavirin
• 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 + RBV.
  Interventions:

  • Drug: PEG-IFN alfa-2b
  • Drug: ribavirin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 2, 2015): 45
• Original Estimated Enrollment (submitted: May 24, 2012): 160
• Actual Study Completion Date: January 26, 2015
• Actual Primary Completion Date: January 26, 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Egypt

Administrative Information

• NCT Number: NCT01606800
• Other Study ID Numbers: 8908B-059; MK-8908B-059 ( Other Identifier: Merck Registration Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: September 2018