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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01172392
• Date of registration: 28/07/2010
• Prospective Registration: Yes
• Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: January 2011
• Target sample size: 185
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01172392
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Marc BOURLIERE, MD
• Affiliation: Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

AgHbs Negativation

Chronic Hepatitis B

Intervention(s)

Drug: Nucleotidic or Nucleosidic Treatment

Drug: Pegylated interferon-alpha-2a

Primary Outcome(s)

HbsAg negativation at week 96 [Time Frame: W96]

Secondary Outcome(s)

Kinetics of HbsAg [Time Frame: W-6, W0, W12, W24 and W48]

Secondary ID(s)

2010-019367-11

ANRS HB 06 PEGAN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG