Clinical trial NCT01750216: An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
Official title: An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 196
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: Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus

Brief summary: This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C genotype 1
* Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
* Confirmed serum positive HCV RNA
* Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
* Co-infection with hepatitis B or HIV
* Post-transplant patients
* End stage renal disease (creatinine clearance \< 15 ml/min)
* Patients treated with immunotherapy
* Pregnant women and male partners of women who are pregnant
* Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter

Primary outcomes:
measure: Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1
timeFrame: approximately 3 years
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 years
measure: Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1
timeFrame: approximately 3 years
measure: Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3)
timeFrame: approximately 3 years
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Chorzow
country: Poland
city: Ciechanow
country: Poland
city: Debica
country: Poland
city: Katowice
country: Poland
city: Koszalin
country: Poland
city: Lancut
country: Poland
city: Lodz
country: Poland
city: Mielec
country: Poland
city: Pulawy
country: Poland
city: Radom
country: Poland
city: Walbrzych
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: