A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
NCT ID: NCT01258101
Last Updated: 2016-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
395 participants
INTERVENTIONAL
2003-05-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peginterferon/Ribavirin 800 mg (24 Weeks)
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin
800 mg orally daily
Peginterferon/Ribavirin 400 mg (24 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin
400 mg orally daily
Peginterferon/Ribavirin 800 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
ribavirin
800 mg orally daily
Peginterferon/Ribavirin 400 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
ribavirin
400 mg orally daily
Interventions
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peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 16 weeks
ribavirin
800 mg orally daily
ribavirin
400 mg orally daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Gratwein, , Austria
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Linz, , Austria
Oberndorf, , Austria
Ried-innkreis, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Villach, , Austria
Wels, , Austria
Wiener Neustadt, , Austria
Countries
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References
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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.
Other Identifiers
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ML17087
Identifier Type: -
Identifier Source: org_study_id
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