Clinical trial NCT00077649: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
Official title: Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-02-13
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HCV RNA Profile During The First 24 Weeks
timeFrame: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
measure: Percentage of Participants With Virological Response Over Time to Week 24
timeFrame: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
measure: Percentage of Participants With Predicted Sustained Virological Response
timeFrame: Week 4 and 12
Secondary outcomes:
measure: Percentage of Participants With Sustained Virological Response
timeFrame: Week 72
measure: Percentage of Participants With Virological Response at the End of the Treatment Period
timeFrame: Week 48
measure: Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
timeFrame: Week 60
measure: Percentage of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 72
measure: Percentage of Participants With Marked Laboratory Abnormalities
timeFrame: Up to Week 60
measure: Percentage of Participants With Abnormal Vital Signs
timeFrame: Up to Week 72
measure: Total BDI-II (Beck Depression Inventory) Scores
timeFrame: From Baseline (Day 1) to Week 72
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Boston
country: United States
state: Massachusetts
city: St Louis
country: United States
state: Missouri
city: Manhasset
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Santurce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: