A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00144469|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 2, 2009
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.
Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: peginterferon alfa-2a Drug: rivavirin||Phase 3|
Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.
All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C|
|Study Start Date :||May 2002|
|Actual Study Completion Date :||March 2005|
- Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).
- Biochemical response (normalization of serum alanine aminotransferase activity),
- Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144469
|Study Director:||Hirokazu Furuta||Chugai Pharmaceutical|