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)

ANRS, Emerging Infectious Diseases

Status and phase

Unknown

Phase 3

Conditions

Chronic Hepatitis B

AgHbs Negativation

Treatments

Drug: Nucleotidic or Nucleosidic Treatment

Drug: Pegylated interferon-alpha-2a

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01172392

ANRS HB 06 PEGAN (Other Identifier)

2010-019367-11

Details and patient eligibility

About

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)

Full 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

Enrollment

185 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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