An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
1 other identifier
observational
697
1 country
27
Brief Summary
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
27 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
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedResults Posted
Study results publicly available
February 10, 2016
CompletedMarch 28, 2016
February 1, 2016
4.8 years
September 22, 2015
January 12, 2016
February 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment \[EOT\] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
24 weeks after EOT (maximum up to 96 Weeks)
Secondary Outcomes (14)
Percentage of Participants With Virologic Response
Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Starting Dose of Ribavirin
24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
24 weeks after EOT (maximum up to 96 weeks)
- +9 more secondary outcomes
Study Arms (1)
Pegasys + Copegus
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
Interventions
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
Eligibility Criteria
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
You may qualify if:
- Participants with serologically confirmed chronic hepatitis C
- Participants using and accepting a double method of contraception
You may not qualify if:
- Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
- Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
- Participants previously treated with pegylated interferon and/or ribavirin
- Hepatitis B and Human Immunodeficiency Virus co-infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Ajka, H-8400, Hungary
Unknown Facility
Balassagyarmat, 2660, Hungary
Unknown Facility
Békéscsaba, 5600, Hungary
Unknown Facility
Budapest, 1067, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, H-1125, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Debrecen, H-4031, Hungary
Unknown Facility
Győr, 9004, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Miskolc, 3529, Hungary
Unknown Facility
Miskolc, H-3501, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Pécs, 7623, Hungary
Unknown Facility
Pécs, 7624, Hungary
Unknown Facility
Sopron, 9400, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Szekszárd, 7100, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Szolnok, 5000, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 23, 2015
Study Start
May 1, 2009
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
March 28, 2016
Results First Posted
February 10, 2016
Record last verified: 2016-02