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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug); ribavirin [Copegus] (Drug); Pioglitazone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Clinical Details

Official title: A Randomized, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy

Secondary outcome:

Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy

Percentage of Participants Achieving Virologic Response

Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72

Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)

Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks

Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period

Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only

Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed

Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.

Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed

Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed

Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed

Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed

Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed

Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed

Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed

Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed

Change From Baseline in Adiponectin Levels at Each Time Point Assessed

Change From Baseline in Leptin Levels at Each Time Point Assessed

Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed

Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- chronic hepatitis C, genotype 1;

- insulin resistance.

Exclusion Criteria:

- other forms of liver disease;

- cirrhosis;

- previous treatment for chronic hepatitis C;

- insulin treatment during prior 2 weeks;

- type 1 diabetes.

Locations and Contacts

San Juan 00936-5067, Puerto Rico

Birmingham, Alabama 35294, United States

Tucson, Arizona 85710, United States

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Indianapolis, Indiana 46202, United States

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Louisville, Kentucky 40202-1798, United States

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Detroit, Michigan 48202-2689, United States

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Kansas City, Missouri 64128, United States

St Louis, Missouri 63110-0250, United States

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Egg Harbour Township, New Jersey 08234, United States

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West Nashville, Tennessee 37205, United States

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Houston, Texas 77030, United States

Lubbock, Texas 79410, United States

Salt Lake City, Utah 84132, United States

Charlottesville, Virginia 22906-0013, United States

Tacoma, Washington 98405, United States

Additional Information

Starting date: January 2008
Last updated: April 10, 2012

Page last updated: August 23, 2015

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