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Trial record 8 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

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)

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ClinicalTrials.gov Identifier: NCT01606800
Recruitment Status : Terminated (The trial was terminated due to change in new standard of therapy during the study period.)
First Posted : May 28, 2012
Results First Posted : February 23, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 28, 2012
Results First Submitted Date  ICMJE January 26, 2016
Results First Posted Date  ICMJE February 23, 2016
Last Update Posted Date October 25, 2018
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date January 26, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 2, 2015)
45
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2012)
160
Actual Study Completion Date  ICMJE January 26, 2015
Actual Primary Completion Date January 26, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Egypt
 
Administrative Information
NCT Number  ICMJE NCT01606800
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP