Clinical trial NCT01392742: An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin
Official title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C treated with Pegasys and ribavirin

Brief summary: This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Serologically confirmed chronic hepatitis C (all genotypes)
* Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion Criteria:

* Coinfection with HIV and/or hepatitis B
* Contraindications according to the SPC for Pegasys/ribavirin

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response (SVR)
timeFrame: 24 weeks after End of treatment (EOT) (up to Week 96)
measure: Percentage of Participants With Relapse
timeFrame: Up to 24 weeks after EOT (up to Week 96)
measure: Percentage of Participants Who Were Non-Responders
timeFrame: Up to 24 weeks after EOT (up to Week 96)
Secondary outcomes:
measure: Percentage of Participants With Positive Predictive Value on SVR at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Positive Predictive Value on SVR at Week 12
timeFrame: Week 12
measure: Correlation of SVR With Rapid Virological Response (RVR)
timeFrame: Up to 24 weeks after EOT (up to Week 96)
measure: Correlation of SVR With Early Virological Response (EVR)
timeFrame: Up to 24 weeks after EOT (up to Week 96)
measure: Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response
timeFrame: Week 4 and 12
measure: Duration of Treatment in Participants With SVR by HCV Genotype
timeFrame: Up to Week 72
measure: Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype
timeFrame: Up to Week 72
measure: Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype
timeFrame: Up to Week 72
measure: Percentage of Participants With Virological Response
timeFrame: 4 weeks after EOT (up to Week 76)
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Mhat - Pleven; Clinic of Gastroenterology
city: Plovdiv
country: Bulgaria
facility: Umhat St. Georgi; Clinical of Gastroenterology
city: Sofia
country: Bulgaria
facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD; Gastroenterology
city: Sofia
country: Bulgaria
facility: Mhat Queenjoanna; Clinic of Gastroenterology
city: Sofia
country: Bulgaria
facility: Military Medical Academy; Gastroenterology
city: Sofia
country: Bulgaria
facility: Mhat St. Ivan Rilski; Clinic of Gastroenterology
city: Stara Zagora
country: Bulgaria
facility: Mhat St. Zagora; Clinical of Gastroenterology
city: Varna
country: Bulgaria
facility: Mhat Sveta Marina; Clinic of Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: