A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
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
1 other identifier
interventional
188
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2004
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 10, 2004
CompletedFirst Posted
Study publicly available on registry
February 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
April 18, 2016
CompletedApril 18, 2016
March 1, 2016
1.9 years
February 10, 2004
February 3, 2016
March 21, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
HCV RNA Profile During The First 24 Weeks
Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Percentage of Participants With Virological Response Over Time to Week 24
Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
72 hours post-dose, Weeks 1, 2, 4, 12, and 24
Percentage of Participants With Predicted Sustained Virological Response
The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was \<0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
Week 4 and 12
Secondary Outcomes (7)
Percentage of Participants With Sustained Virological Response
Week 72
Percentage of Participants With Virological Response at the End of the Treatment Period
Week 48
Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period
Week 60
Percentage of Participants With Adverse Events and Serious Adverse Events
Up to Week 72
Percentage of Participants With Marked Laboratory Abnormalities
Up to Week 60
- +2 more secondary outcomes
Study Arms (4)
PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
ACTIVE COMPARATORParticipants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
EXPERIMENTALParticipants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks
PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
EXPERIMENTALParticipants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
EXPERIMENTALParticipants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
Interventions
600mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Long Beach, California, 90822, United States
Unknown Facility
San Diego, California, 92105, United States
Unknown Facility
San Diego, California, 92154, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
Bradenton, Florida, 34209, United States
Unknown Facility
Gainesville, Florida, 32610-0214, United States
Unknown Facility
Jacksonville, Florida, 32207, United States
Unknown Facility
Wellington, Florida, 33414, United States
Unknown Facility
Honolulu, Hawaii, 96817, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
St Louis, Missouri, 63104, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7584, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Cincinnati, Ohio, 45267-0595, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
Charlottesville, Virginia, 22906-0013, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Santurce, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2004
First Posted
February 13, 2004
Study Start
January 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 18, 2016
Results First Posted
April 18, 2016
Record last verified: 2016-03