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
|ClinicalTrials.gov Identifier: NCT00800735|
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : September 13, 2013
Last Update Posted : October 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Pegylated-interferon alfa-2a Drug: Ribavirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter Protocol Providing Pegylated-interferon Alfa-2a (PEGASYS®) as Monotherapy or in Combination With Ribavirin (COPEGUS®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: 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.
Drug: Pegylated-interferon alfa-2a
Pegylated-interferon alfa-2a was administered subcutaneously once weekly.
Other Names:Drug: 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.
- Percentage of Participants Who Experienced at Least 1 Adverse Event. [ Time Frame: Baseline through 24 weeks after the end of treatment (up to 72 weeks) ]An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800735
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|Study Director:||Clinical Trials||Hoffmann-La Roche|