A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
NCT ID: NCT00087568
Last Updated: 2016-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
57 participants
INTERVENTIONAL
2003-01-31
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-Responders
Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks.
Ribavirin
1000/1200mg po bid for 36 or 60 weeks
peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Non-Tolerators
Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.
Ribavirin
1000/1200mg po bid for 36 or 60 weeks
peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Interventions
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Ribavirin
1000/1200mg po bid for 36 or 60 weeks
peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
Eligibility Criteria
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Inclusion Criteria
* CHC infection, genotype 1
* unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
* use of 2 forms of contraception during the study in both men and women
Exclusion Criteria
* medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
* patients with decompensated cirrhosis
* patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
18 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_DIRECTOR
Hoffmann-La Roche
Locations
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Bakersfield, California, United States
Pasadena, California, United States
San Diego, California, United States
San Mateo, California, United States
Bradenton, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Austell, Georgia, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Bayside, New York, United States
Brooklyn, New York, United States
Manhasset, New York, United States
New York, New York, United States
Valhalla, New York, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Countries
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References
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Bonkovsky HL, Tice AD, Yapp RG, Bodenheimer HC Jr, Monto A, Rossi SJ, Sulkowski MS. Efficacy and safety of peginterferon alfa-2a/ribavirin in methadone maintenance patients: randomized comparison of direct observed therapy and self-administration. Am J Gastroenterol. 2008 Nov;103(11):2757-65. doi: 10.1111/j.1572-0241.2008.02065.x. Epub 2008 Aug 5.
Rustgi VK, Esposito S, Hamzeh FM, Shiffman ML. Peginterferon alfa-2a/ribavirin in hepatitis C virus patients nontolerant or nonresponsive to peginterferon alfa-2b/ribavirin. Aliment Pharmacol Ther. 2008 Mar 1;27(5):433-40. doi: 10.1111/j.1365-2036.2007.03587.x. Epub 2007 Dec 10.
Other Identifiers
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ML16965
Identifier Type: -
Identifier Source: org_study_id
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