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. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545233

Purpose

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 1000-1600mg/day (according to body weight) or b)16 weeks of pioglitazone (30mg daily for 8 weeks, then 45mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600mg/day + pioglitazone 45mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a [Pegasys] Drug: Copegus Drug: Pioglitazone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Insulin Ribavirin Pioglitazone Pioglitazone hydrochloride Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in HCV RNA [ Time Frame: Week 12 of anti-HCV treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with undetectable HCV RNA, percentage of patients with >2log10 decrease in HCV RNA, change in log10 HCV RNA. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Glycemic and lipid control, and insulin resistance. [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters, beta-type natriuretic peptide [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	154
Study Start Date:	November 2007
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 48 weeks Drug: Copegus 1000-1600mg po / day for 48 weeks Drug: Pioglitazone 30mg increasing to 45mg daily for 64 weeks
Active Comparator: 2	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 48 weeks Drug: Copegus 1000-1600mg po / day for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545233

Show 66 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545233 History of Changes
Other Study ID Numbers:	ML21301
Study First Received:	October 16, 2007
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism

Glucose Metabolism Disorders
Metabolic Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Pioglitazone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012