Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Gainesville, Florida 32610


Purpose:

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.


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.


Study is Available At:


Original ID:

NV17318


NCT ID:

NCT00077649


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:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

188


Enrollment Type:

Actual


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
Name:Copegus
Description:600mg po bid for 48 weeks
Arm Name:1
Other Name:PEGASYS
Intervention Type:Drug
Name:Copegus
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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.