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

NCT01770223 | Withdrawn Phase 4

• 2 other identifiers: 3034-1132012-002771-33
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment

  Week 72

Secondary Outcomes (1)

• Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)

  Baseline up to 8 weeks

Study Arms (1)

Boceprevir + PegIFN-2b + RBV

EXPERIMENTAL

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).

Drug: boceprevir; Biological: PegIFN-2b; Drug: RBV

Interventions

boceprevir DRUG

Also known as: SCH 503034

Boceprevir + PegIFN-2b + RBV

PegIFN-2b BIOLOGICAL

Also known as: Peginterferon alfa-2b, PegIntron, SCH 054031

Boceprevir + PegIFN-2b + RBV

RBV DRUG

Also known as: Ribavirin, Rebetol

Boceprevir + PegIFN-2b + RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 20, 2017

Record last verified: 2017-03