Clinical trial NCT01258101: A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
Official title: Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-10
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Chronic hepatitis C, genotype 2 or 3
* Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
* Abdominal sonography within 3 months prior to study start

Exclusion Criteria:

* Previous interferon and/or pegylated interferon and ribavirin therapy
* Liver cirrhosis, class B or C (Child-Pugh)
* Systemic anti-neoplastic or immunomodulatory treatment \<=6 months before study drug
* History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
* Decompensated liver disease
* Positive for HIV

Primary outcomes:
measure: Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
timeFrame: Up to Week 48 (24 weeks post completion of the treatment)
measure: Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
timeFrame: At Week 24 and Week 48
Secondary outcomes:
measure: Percentage of Participants With Virological Response at the End of the Treatment
timeFrame: At Week 16 and Week 24
measure: Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
timeFrame: At Week 16 and Week 24
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Up to Week 48
measure: Median Hemoglobin Levels at End of Treatment
timeFrame: At Week 16 and Week 24
measure: Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
timeFrame: At Baseline (Week 0) and Weeks 16, 24 and 48
measure: Mean FSS Scores at Baseline and Weeks 16, 24 and 48
timeFrame: At Baseline (Week 0) and Weeks 16, 24 and 48
measure: Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
timeFrame: At Baseline (Week 0) and Weeks 16, 24 and 48
measure: Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
timeFrame: At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48
measure: Time to Viral Response
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Gratwein
country: Austria
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Linz
country: Austria
city: Oberndorf
country: Austria
city: Ried-innkreis
country: Austria
city: Salzburg
country: Austria
city: Villach
country: Austria
city: Wels
country: Austria
city: Wiener Neustadt
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Maieron A, Metz-Gercek S, Scherzer TM, Laferl H, Fischer G, Bischof M, Gschwantler M, Ferenci P. Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial. BMC Res Notes. 2011 Jun 29;4:220. doi: 10.1186/1756-0500-4-220.