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

Chronic Hepatitis B Clinical Trial

Official title:

Long Term Follow-up of Pegylated-Interferon Alpha-2b and Lamivudine Combination Therapy in Patients With Chronic HBV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146705
• Other study ID #: LTFU HBV 99-01
• Status: Completed
• Phase: N/A
• First received: September 5, 2005
• Last updated: July 31, 2007
• Start date: May 2005
• Est. completion date: September 2006

Study information

• Verified date: July 2007
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Procedure:
• blood samples are taken once

Locations

Country	Name	City	State
Netherlands	University Medical Center Rotterdam	Rotterdam	dr Molewaterplein 40

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, Simon C, So TM, Gerken G, de Man RA, Niesters HG, Zondervan P, Hansen B, Schalm SW; HBV 99-01 Study Group; Rotterdam Foundation for Liver Research. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005 Jan 8-14;365(9454):123-9. — View Citation

van Nunen AB, Hansen BE, Suh DJ, Löhr HF, Chemello L, Fontaine H, Heathcote J, Song BC, Janssen HL, de Man RA, Schalm SW. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut. 2003 Mar;52(3):420-4. — View Citation

van Zonneveld M, Honkoop P, Hansen BE, Niesters HG, Darwish Murad S, de Man RA, Schalm SW, Janssen HL. Long-term follow-up of alpha-interferon treatment of patients with chronic hepatitis B. Hepatology. 2004 Mar;39(3):804-10. — View Citation