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Trial record 43 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Long Term Effects of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C/B Co-Infection and 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. Identifier: NCT00361179
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : August 7, 2006
Hoffmann-La Roche
Information provided by:
National Taiwan University Hospital

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Enrollment : 320 participants
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
Study Start Date : May 2006
Study Completion Date : December 2011

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00361179

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00361179     History of Changes
Other Study ID Numbers: 9561706020
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: August 7, 2006
Last Verified: August 2006
Keywords provided by National Taiwan University Hospital:
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepadnaviridae Infections
Parasitic Diseases
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents