Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant
|ClinicalTrials.gov Identifier: NCT00466219|
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : April 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Ribavirin Drug: Pegylated interferon alpha2a||Phase 3|
The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any).
The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2002|
|Study Completion Date :||December 2006|
- Biochemical (normalization of serum transaminases levels),
- virological (disappearance of HCV RNA from serum)
- and histological (amelioration of the histological signs of hepatitis) response.
- Correlation of the above outcome measures with early on-treatment HCV RNA dynamics (if applicable).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466219
|Principal Investigator:||Francesco Negro, MD||University Hospital, Geneva|