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Trial information
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.
Status: Recruiting
Protocol number: ML21301
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief 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 1000-1600mg/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. Target sample size is
240.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Change in HCV RNA Time frame: Week 12 of anti-HCV treatment
Key secondary outcomes: 1. 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
2. Glycemic and lipid control, and insulin resistance. Time frame: At intervals throughout study
3. AEs, laboratory parameters, beta-type natriuretic peptide Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 10/15/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:United States - Birmingham, AL
- Tucson , AZ
- Anaheim, CA
- Fresno, CA
- La Jolla, CA
- Loma Linda, CA
- Los Angeles, CA
- Merced, CA
- Palo Alto, CA
- Pasadena, CA
- San Clemente, CA
- San Mateo, CA
- Englewood, CO
- Littleton, CO
- Hartford, CT
- Atlanta, GA
- Marietta, GA
- Chicago, IL
- Downers Grove, IL
- Indianapolis , IN
- Iowa City, IA
- Louisville, KY
- New Orleans, LA
- Portland, ME
- Baltimore, MD
- Boston, MA
- Burlington, MA
- Detroit, MI
- Duluth, MN
- Tupelo, MS
- Kansas City, MO
- Lebanon, NH
- Egg Harbour Township, NJ
- Hackensack, NJ
- Bayside, NY
- Manhasset, NY
- New York, NY
- Asheville, NC
- Charlotte, NC
- Durham, NC
- Cincinnati, OH
- Cleveland, OH
- Dayton, OH
- Tulsa , OK
- Portland, OR
- Philadelphia, PA
- San Juan, PR
- Columbia, SC
- Germantown, TN
- Nashville, TN
- West Nashville, TN
- Dallas, TX
- Fort Sam Houston, TX
- Houston, TX
- Lubbock, TX
- Salt Lake City, UT
- Charlottesville, VA
- Seattle, WA
- Tacoma, WA
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