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Long Term Effects of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/B Co-Infection and Chronic Hepatitis C

This study has been completed.
Hoffmann-La Roche
Information provided by:
National Taiwan University Hospital Identifier:
First received: August 4, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

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.

Coinfection With Hepatitis B Virus and Hepatitis C Virus Monoinfection With Hepatitis C Virus

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 320
Study Start Date: May 2006
Estimated Study Completion Date: December 2011
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who were randomized, treated and returned for follow up in the ML17862 protocol will be eligible for inclusion in this protocol

Exclusion Criteria:

  • Patients unwilling to provide informed consent or abide by the requirements of the study.
  • Patients who have already initiated anti-HCV or HBV treatment, approved or investigational since completion of the original protocol
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Please refer to this study by its identifier: NCT00361179

China, Taiwan
Pei-Jer Chen
Taipei city, Taiwan, China, 100
Sponsors and Collaborators
National Taiwan University Hospital
Hoffmann-La Roche
Principal Investigator: Pei-Jer Chen, M.D.; Ph.D. National Taiwan University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00361179     History of Changes
Other Study ID Numbers: 9561706020
Study First Received: August 4, 2006
Last Updated: August 4, 2006

Keywords provided by National Taiwan University Hospital:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis B
Hepatitis C, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Parasitic Diseases
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017