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Long Term Follow-up of Pegylated-Interferon Alpha-2b
This study has been completed.
Sponsored by: Foundation for Liver Research
Information provided by: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00146705
  Purpose

The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with or without the addition of lamivudine in patients with chronic hepatitis B


Condition Intervention
Chronic Hepatitis B
Procedure: blood samples are taken once

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Lamivudine Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Long Term Follow-up of Pegylated-Interferon Alpha-2b and Lamivudine Combination Therapy in Patients With Chronic HBV Infection

Further study details as provided by Foundation for Liver Research:

Enrollment: 266
Study Start Date: May 2005
Study Completion Date: September 2006
Detailed Description:

Interferon alpha therapy is a generally accepted agent for the treatment of chronic HBV infection and effective in about one third of patients. Recently, in the HBV 99-01 study, pegylated interferon alpha-2b (PEG-IFN) has been shown to be effective in HBeAg-positive patients with chronic hepatitis B. In this study, 266 patients were randomized to receive PEG-IFN in combination with either lamivudine or placebo for 52 weeks.

Thirty-six percent of patients receiving monotherapy and thirty-five percent receiving combination therapy had lost serum HBeAg at the end of the 26 week post-treatment follow-up period and there was no difference between treatment groups (P = 0.91). More patients on combination therapy initially seroconverted (44% of patients, compared with 29% on monotherapy; P = 0.01) at the end of treatment but relapsed during follow-up. Similar response patterns were seen when response was assessed by DNA suppression and change in ALT levels.

In contrast to nucleoside analogues, such as lamivudine and adefovir dipivoxil, the virological and biochemical response to standard alpha-interferon has been shown to be durable after treatment discontinuation.In addition, standard alpha-interferon leads to improved survival and reduction of hepatocellular carcinoma in chronic hepatitis B patients.Pegylated interferons have shown to be effective in HBeAg-positive chronic hepatitis B patients, but the durability of the response and long-term outcome of treatment have yet to be established.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic Hepatitis B who participated in the HBV 99-01 study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146705

Locations
Netherlands, dr Molewaterplein 40
University Medical Center Rotterdam
Rotterdam, dr Molewaterplein 40, Netherlands, 3015 GD
Sponsors and Collaborators
Foundation for Liver Research
Investigators
Principal Investigator: Harry LA Janssen, MD PhD Department of Gastroenterology and Hepatology, University Medical Center Rotterdam, Rotterdam, the Netherlands
  More Information

Publications:
Study ID Numbers: LTFU HBV 99-01
Study First Received: September 5, 2005
Last Updated: July 31, 2007
ClinicalTrials.gov Identifier: NCT00146705  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
chronic HBV
Peginterferon
long term follow-up

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Lamivudine
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis B, Chronic
Peginterferon alfa-2b
Hepatitis B
DNA Virus Infections
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009