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

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Roche Pharma AG
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

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