A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (PEGAN)

March 28, 2013 updated by: ANRS, Emerging Infectious Diseases

A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan

The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s).

The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.

It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13008
        • Hôpital Saint Joseph, Service d'hépatogastroentérologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive Hbs Ag
  • Negative HbeAg
  • Plasma HBV DNA undetectable at pre-inclusion ever since 12 months
  • ALT less than or equal to 5 times the upper limit of normal
  • Non cirrhotic or Not Decompensated Cirrhosis (Child Pugh <7)
  • Undetectable hepatocellular carcinoma in liver scan and / or alpha-fetoprotein rate <50 ng / ml
  • Unchanged nucleoside (s) and / or nucleotide (s) treatment for at least three months (and not including telbivudine)
  • Negative pregnancy test for childbearing women
  • Signed informed consent
  • Use of contraception for childbearing women

Exclusion Criteria:

  • Polymorphonuclear neutrophils <1500/mm3
  • Platelets <70.000/mm3
  • Co-infections with HIV, HCV and / or HDV
  • Prolonged excessive consumption of alcohol
  • Active intravenous drug addiction
  • Immunomodulators Treatment(eg interferons), ever since one year
  • Immunosuppressive treatments terminated ever since one year
  • Telbivudine treatment
  • Long course steroid treatment (more than 4 weeks) by oral way
  • History of severe epilepsy or current use of anticonvulsants
  • Severe heart disease (eg heart failure stage III or IV NYHA class, myocardial infarction less than 6 months, ventricular arrhythmia requiring treatment, unstable angina or other significant cardiovascular disease)
  • Chronic liver disease other than HBV-related (hemochromatosis, autoimmune hepatitis, metabolic liver disease, including Wilson's disease and a deficiency of alpha1-antitrypsin deficiency, alcoholic liver disease, exposure to toxins)
  • Presence or suspicion of cancer or a history of cancer (except basal cell carcinoma or in situ carcinoma) within 5 years preceding the randomization
  • Thyroid uncontrolled disease, abnormal TSH, elevated thyroid antibodies and clinical manifestations of thyroid dysfunction
  • History of autoimmune disease (inflammatory digestive, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis ....) Or presence of autoantibodies at a significant rate
  • Renal impairment (creatinine clearance <50 ml / min using the Cockroft formula), renal transplantation, hemodialysis
  • Hypersensitivity to the active substance, interferon alpha or any component
  • History of depression or psychiatric disorders and uncontrolled depression or uncontrolled psychiatric disorders
  • Pregnancy or breastfeeding, or wish of pregnancy during the study period.
  • Patients under legal protection or unable to express their consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PegIFN + Nucleosidic or Nucleotidic Analog
Drug: Pegylated interferon-alpha-2a
180 mcg / wk / SC from D0 to W48
ACTIVE_COMPARATOR: Nucleosidic or Nucleotidic Analog
Drug: Nucleotidic or Nucleosidic Treatment
Analog treatment according to investigators practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbsAg negativation at week 96
Time Frame: W96
Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
W96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinetics of HbsAg
Time Frame: W-6, W0, W12, W24 and W48
Kinetics of HbsAg under treatment at W-6, W0, W12, W24 and W48 and after discontinuation of PegIFN alpha 2a at W72, W20 and W144
W-6, W0, W12, W24 and W48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Roche Pharma AG

Investigators

  • Study Chair: Marc BOURLIERE, MD, Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (ESTIMATE)

July 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-019367-11
  • ANRS HB 06 PEGAN (OTHER: FrenchAIDS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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