Expired Study
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Gainesville, Florida 32610


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.


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infect

Official 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

Overall Status:


Study Phase:

Phase 4



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:January 2004
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 1, 2015
First Received Date:February 10, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Viral response compared to baseline\n
Time Frame:Week 24
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:SVR and end of treatment virological response\n\n
Time Frame:Week 48
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Virological response
Time Frame:Week 60
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:AEs, laboratory parameters, vital signs, Beck Depression Inventory
Time Frame:Throughout study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description:600mg po bid for 48 weeks
Arm Name:1
Other Name:PEGASYS
Intervention Type:Drug
Description:800mg po bid for 48 weeks
Arm Name:2
Intervention Type:Drug
Name:peginterferon alfa-2a [Pegasys]
Description:180 micrograms sc weekly for 48 weeks
Arm Name:1
Intervention Type:Drug
Name:peginterferon alfa-2a [Pegasys]
Description:270 micrograms sc weekly for 48 weeks
Arm Name:3

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Study Arm Type:Experimental
Arm Name:2
Study Arm Type:Experimental
Arm Name:3
Study Arm Type:Experimental
Arm Name:4

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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