Clinical trial NCT00192647: A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Official title: A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 896
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic CHC, genotype 1
* Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
* Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
* Compensated liver disease
* Naive to interferon-based therapy for CHC infection

Exclusion Criteria:

* Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
* Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
* Chronic liver disease other than CHC infection

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
timeFrame: Weeks 48
measure: Percentage of Participants With Virological Responses Over Time
timeFrame: Weeks 4, 8, 12, and 24
measure: Percentage of Participants With Relapse of End-of-treatment Virological Response
timeFrame: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
measure: Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
timeFrame: Weeks 4, 12, and 72
measure: Change From Baseline in Log10 HCV RNA Values
timeFrame: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Rosario
country: Argentina
city: Adelaide
country: Australia
city: Adelaide
country: Australia
city: Bankstown
country: Australia
city: Box Hill
country: Australia
city: Brisbane
country: Australia
city: Cottontree
country: Australia
city: Darlinghurst
country: Australia
city: Douglas
country: Australia
city: Fitzroy
country: Australia
city: Fremantle
country: Australia
city: Geelong
country: Australia
city: Greenslopes
country: Australia
city: Kingswood
country: Australia
city: Lismore
country: Australia
city: Liverpool
country: Australia
city: Liverpool
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Miranda
country: Australia
city: Nedlands
country: Australia
city: New Lambton Heights
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Sydney
country: Australia
city: Victoria
country: Australia
city: Woden
country: Australia
city: Wollongong
country: Australia
city: Woolloongabba
country: Australia
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Mississauga
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Riccarton, Christchurch
country: New Zealand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: