Status:
UNKNOWN
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
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Chronic Hepatitis B
AgHbs Negativation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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)
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 durat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01172392
Start Date
January 1 2011
End Date
June 1 2015
Last Update
March 29 2013
Active Locations (1)
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1
Hôpital Saint Joseph, Service d'hépatogastroentérologie
Marseille, France, 13008