Clinical trial NCT02557646: An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-23
Enrollment: 697
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: Inclusion Criteria:

* Participants with serologically confirmed chronic hepatitis C
* Participants using and accepting a double method of contraception

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
timeFrame: 24 weeks after EOT (maximum up to 96 Weeks)
Secondary outcomes:
measure: Percentage of Participants With Virologic Response
timeFrame: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
measure: Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
timeFrame: Up to EOT (maximum up to 72 weeks)
measure: Percentage of Participants With SVR According to Starting Dose of Ribavirin
timeFrame: 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
timeFrame: Up to EOT (maximum up to 72 weeks)
measure: Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
timeFrame: 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
timeFrame: Up to EOT (maximum up to 72 weeks)
measure: Percentage of Participants With SVR According to Dose Reduction of Ribavirin
timeFrame: 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
timeFrame: Up to EOT (maximum up to 72 weeks)
measure: Percentage of Participants With SVR According to IL-28B Polymorphism
timeFrame: 24 weeks after EOT (maximum up to 96 Weeks)
measure: Percentage of Participants With Viral Relapse or Breakthrough
timeFrame: Up to 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
timeFrame: Up to 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
timeFrame: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
timeFrame: Up to 24 weeks after EOT (maximum up to 96 weeks)
measure: Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
timeFrame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Other outcomes:
Locations:
city: Ajka
country: Hungary
city: Balassagyarmat
country: Hungary
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Pecs
country: Hungary
city: Sopron
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Székesfehérvár
country: Hungary
city: Tatabánya
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: