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Long Term Follow-up of Pegylated-Interferon Alpha-2b

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ClinicalTrials.gov Identifier: NCT00146705
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : August 1, 2007
Information provided by:
Foundation for Liver Research

Brief Summary:
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 or disease Intervention/treatment
Chronic Hepatitis B Procedure: blood samples are taken once

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.

Study Type : Observational
Actual Enrollment : 266 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Long Term Follow-up of Pegylated-Interferon Alpha-2b and Lamivudine Combination Therapy in Patients With Chronic HBV Infection
Study Start Date : May 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with chronic Hepatitis B who participated in the HBV 99-01 study

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 ClinicalTrials.gov identifier (NCT number): NCT00146705

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00146705     History of Changes
Other Study ID Numbers: LTFU HBV 99-01
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: August 1, 2007
Last Verified: July 2007

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

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs