A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
NCT ID: NCT00800735
Last Updated: 2013-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2009-04-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pegylated-interferon alfa-2a plus ribavirin
Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Pegylated-interferon alfa-2a
Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
Ribavirin
Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Interventions
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Pegylated-interferon alfa-2a
Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
Ribavirin
Participants received ribavirin with food, as the bioavailability of ribavirin is increased when taken with food. Ribavirin was administered as split doses, that is, 2 doses were given 12 hours apart, 1 in the morning and 1 in the evening. Participants received either 1000 or 1200 mg ribavirin per day according to body weight: 400 mg (2 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing \< 75 kg or 600 mg (3 tablets) in the morning and 600 mg (3 tablets) in the evening for participants weighing ≥ 75 kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C (CHC) patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.
Exclusion Criteria
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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Sacramento, California, United States
San Francisco, California, United States
Lutherville, Maryland, United States
Manhasset, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Vienna, , Austria
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Clichy, , France
Berlin, , Germany
Cologne, , Germany
Frankfurt am Main, , Germany
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Countries
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Other Identifiers
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2008-002022-10
Identifier Type: -
Identifier Source: secondary_id
NV21928
Identifier Type: -
Identifier Source: org_study_id