Long Term Effects of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/B Co-Infection and Chronic Hepatitis C
|ClinicalTrials.gov Identifier: NCT00361179|
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : August 7, 2006
Chronic hepatitis C may relapse in simple chronic hepatitis C patients who initially obtained sustained virologic responses. Although the HCV SVR could be maintained in around 90%, the remaining 10% of these patients may develop hepatitis C relapse during follow-up. Therefore, it is important to follow up the long-term of these patients with dual chronic hepatitis B and C.
From another aspect, for the treatment of chronic hepatitis B, the virologic and serologic responses may also not be durable. Alternatively, previous studies suggested that the therapeutic efficacy might not be seen in the study period, and incremental response might occur during long-term follow-up. Therefore it is also important to clarify the long-term outcome of treatment in this dually infected population.
Evaluation of the long term effects of treatment with peginterferon alfa-2a plus ribavirin for patients with chronic hepatitis C/ hepatitis B co-Infection and chronic hepatitis C in the original study ML17862 is important. This present protocol is thus to assess whether the HCV SVR is sustained and to assess the durability of the HBV virologic and serologic responses or any incremental response during a 5-year follow-up period, including six months after end of the therapy in the original study and an additional 4 and half years in this project (5 years overall follow-up after the end of treatment). Specifically, we wish to assess the (1) sustained virologic response (SVR) of HCV in both populations, (2) incidence of HBsAg loss and HBsAg seroconversion (HBsAg loss and appearance of anti-HBs) in dually infected population, (3) ALT normalization or flare off-treatment during both populations, (4) reductions of HCV RNA from the original baseline levels in the two patient populations, and (5) reduction of serum HBV DNA off-treatment in the dually infected population.
|Condition or disease|
|Coinfection With Hepatitis B Virus and Hepatitis C Virus Monoinfection With Hepatitis C Virus|
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|Study Type :||Observational|
|Estimated Enrollment :||320 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||An Extension, Observational Protocol to Evaluate the Long Term Effects of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/B Co-Infection and Chronic Hepatitis C in the Original Study ML17862|
|Study Start Date :||May 2006|
|Estimated Study Completion Date :||December 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361179
|Taipei city, Taiwan, China, 100|
|Principal Investigator:||Pei-Jer Chen, M.D.; Ph.D.||National Taiwan University Hospital|