|
|
 |
|
 |
|
Trial information
Latino Study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
Status: Completed
Protocol number: ML18179
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of PEGASYS plus ribavirin on sustained virological response in treatment-naïve Latino White patients compared with non-Latino Caucasian patients with chronic hepatitis C, genotype 1
Brief summary: This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.
Target sample size is 540.
Study phase: IV
Study type: Interventional; Treatment; Open Label; Active; Single Group; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Percentage of patients with sustained virologic response Time frame: 24 weeks post-treatment
Key secondary outcomes: 1. Percentage of patients with early virologic response Time frame: Weeks 4 and 12
2. Percentage of patients with virologic response Time frame: Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment
3. AEs, laboratory parameters, premature withdrawals Time frame: Throughout study
Inclusion criteria: - adult patients 18-65 years of age
- CHC, genotype 1
- serologic evidence of CHC infection by an antibody test
- chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
- compensated liver disease
- use of 2 forms of contraception during the study in both men and women
Exclusion criteria: - previous interferon or ribavirin therapy
- systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
- medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
- decompensated liver disease
- women who are pregnant or breastfeeding
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:United States - Scottsdale, AZ
- Tucson , AZ
- Anaheim, CA
- Fresno, CA
- Lancaster, CA
- Los Angeles, CA
- Palo Alto, CA
- Redlands, CA
- Sacramento, CA
- San Bernardino, CA
- San Diego , CA
- San Luis Obispo, CA
- Ventura, CA
- Pueblo, CO
- Boca Raton, FL
- Miami, FL
- North Miami Beach , FL
- Plantation, FL
- Sarasota , FL
- Austell, GA
- Chicago, IL
- Gurnee, IL
- Baton Rouge, LA
- Baltimore, MD
- Framingham, MA
- Worcester, MA
- St Louis, MO
- Vineland, NJ
- Bayside, NY
- New York, NY
- Rochester, NY
- Chapel Hill, NC
- Fayetteville, NC
- Philadelphia, PA
- Ponce, PR
- Santurce, PR
- Nashville, TN
- Dallas, TX
- Fort Sam Houston, TX
- Galveston, TX
- Houston, TX
- San Antonio, TX
- Salt Lake City, UT
- Fairfax , VA
- Seattle, WA
- Tacoma, WA
|
|
 |
|
