Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Status: Completed
Protocol number: NV17318
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of PEGASYS and ribavirin combination therapy on viral kinetics and virologic response in interferon-naïve patients with chronic hepatitis C genotype 1 infection
Brief summary: The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is 160.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. Viral response compared to baseline
Time frame: Week 24
Key secondary outcomes: 1. SVR and end of treatment virological response
Time frame: Week 48
2. Virological response Time frame: Week 60
3. AEs, laboratory parameters, vital signs, Beck Depression Inventory Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- body weight >85kg (187lbs);
- CHC (genotype 1);
- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- use of 2 forms of contraception during study and 6 months after the study in both men and women.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- male partners of women who are pregnant;
- conditions associated with decompensated liver disease;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection;
- previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
United States
- La Jolla, CA
- Long Beach, CA
- San Diego , CA
- Farmington, CT
- Gainesville, FL
- Jacksonville, FL
- Sarasota , FL
- Wellington, FL
- Honolulu, HI
- Chicago, IL
- Iowa City, IA
- Boston, MA
- St Louis, MO
- Manhasset, NY
- Chapel Hill, NC
- Charlotte, NC
- Cincinnati, OH
- Santurce, PR
- Houston, TX
- Salt Lake City, UT
- Charlottesville, VA
- Richmond, VA
