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A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

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ClinicalTrials.gov Identifier: NCT01770223
Recruitment Status : Withdrawn
First Posted : January 17, 2013
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

January 15, 2013
January 17, 2013
March 20, 2017
January 2014
December 2015   (Final data collection date for primary outcome measure)
Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment [ Time Frame: Week 72 ]
Same as current
Complete list of historical versions of study NCT01770223 on ClinicalTrials.gov Archive Site
Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) [ Time Frame: Baseline up to 8 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)
An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy
This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C
  • Drug: boceprevir
    Other Name: SCH 503034
  • Biological: PegIFN-2b
    Other Names:
    • Peginterferon alfa-2b
    • PegIntron
    • SCH 054031
  • Drug: RBV
    Other Names:
    • Ribavirin
    • Rebetol
Experimental: Boceprevir + PegIFN-2b + RBV
All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).
Interventions:
  • Drug: boceprevir
  • Biological: PegIFN-2b
  • Drug: RBV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
100
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA)
  • Hepatitis C virus genotype 1
  • Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) > 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit)
  • Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs
  • No response, partial response, or relapse after previous therapy
  • Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
  • If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)

Exclusion criteria:

  • Coinfection with HCV genotypes other than HCV-GT1
  • Evidence of decompensated liver disease
  • History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension
  • History or signs or symptoms or evidence of hepatocellular carcinoma (HCC)
  • History of organ transplant
  • Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Severe psychiatric disease
  • Inadequately controlled thyroid function
  • Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc)
  • Substances abuse
  • Alcohol intake >20 grams/day for females and >30 grams/day for males
  • History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01770223
3034-113
2012-002771-33 ( EudraCT Number )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

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