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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01172392
First received: July 28, 2010
Last updated: March 28, 2013
Last verified: February 2013
History of Changes

July 28, 2010
March 28, 2013
January 2011
June 2015   (final data collection date for primary outcome measure)
HbsAg negativation at week 96 [ Time Frame: W96 ] [ Designated as safety issue: No ]
Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
Same as current
Complete list of historical versions of study NCT01172392 on ClinicalTrials.gov Archive Site
Kinetics of HbsAg [ Time Frame: W-6, W0, W12, W24 and W48 ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
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
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)

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis B
  • AgHbs Negativation
  • Drug: Pegylated interferon-alpha-2a
    180 mcg / wk / SC from D0 to W48
  • Drug: Nucleotidic or Nucleosidic Treatment
    Analog treatment according to investigators practice
  • Experimental: PegIFN + Nucleosidic or Nucleotidic Analog
    Intervention: Drug: Pegylated interferon-alpha-2a
  • Active Comparator: Nucleosidic or Nucleotidic Analog
    Intervention: Drug: Nucleotidic or Nucleosidic Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
185
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01172392
2010-019367-11, ANRS HB 06 PEGAN
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Roche Pharma AG
Study Chair: Marc BOURLIERE, MD Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP