A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
1 other identifier
interventional
2,695
1 country
20
Brief Summary
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2002
Longer than P75 for phase_4
20 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
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 2, 2016
November 1, 2016
7.1 years
July 6, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
safety and tolerability with regard to clinical AEs and laboratory parameters
assessed every 2 weeks throughout study and after 8 weeks follow-up
Secondary Outcomes (1)
safety with regard to hematological parameters
assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients \>/= 18 years of age
- serologic evidence of chronic hepatitis C infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
You may not qualify if:
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Afula, 18101, Israel
Unknown Facility
Ashkelon, 78278, Israel
Unknown Facility
Bat Yam, Israel
Unknown Facility
Beersheba, 84105, Israel
Unknown Facility
Hadera, 38100, Israel
Unknown Facility
Haifa, 31096, Israel
Unknown Facility
Haifa, 33394, Israel
Unknown Facility
Haifa, 34362, Israel
Unknown Facility
Holon, 58100, Israel
Unknown Facility
Jerusalem, 91120, Israel
Unknown Facility
Kfar Saba, 44281, Israel
Unknown Facility
Nahariya, 22100, Israel
Unknown Facility
Nazareth, Israel
Unknown Facility
Petah Tikva, 49100, Israel
Unknown Facility
Petah Tikva, Israel
Unknown Facility
Ramat Gan, 52621, Israel
Unknown Facility
Rehovot, 76100, Israel
Unknown Facility
Safed, 13110, Israel
Unknown Facility
Tel Aviv, 6423906, Israel
Unknown Facility
Ẕerifin, 6093000, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 16, 2009
Study Start
October 1, 2002
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11