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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01770223
• Other study ID #: 3034-113
• Secondary ID: 2012-002771-33
• Status: Withdrawn
• Phase: Phase 4
• First received: January 15, 2013
• Last updated: March 17, 2017
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Insulin Resistance

Intervention

Drug:
• boceprevir

Biological:
• PegIFN-2b

Drug:
• RBV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment		Week 72
Secondary	Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)		Baseline up to 8 weeks