A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml (New Switch)

Chongqing Medical University

Status

Unknown

Conditions

Chronic Hepatitis B

Treatments

Drug: Peginterferon alfa 2a

Study type

Interventional

Funder types

Other

Identifiers

NCT01464281

ML27928

Details and patient eligibility

About

A Randomized, open-label, multicenter study.

The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups:

Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.

All the patients will be followed up for 48 weeks after discontinuation of the study medication.

Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.

Full description

eligibility criteria: Men and women old of 18 to 65 years with chronic hepatitis B HBeAg positive treated with nucleoside and/or nucleotide analogues for 1-2 years and with partial response (HBeAg loss and HBV DNA <1000copies/ml).

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients on-treatment with NAs (ADV, ETV or LAM) for 1-3 years, having achieved HBeAg loss at screening, and HBV DNA <200IU/ml for at least 48 weeks
Male and female patients ≥ 18 to 65 years of age
Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
Compensated liver disease (Child-Pugh <6)
Absence of hepatocellular carcinoma on liver imaging and/or alfa fetoprotein < 50 ng/ml
Negative urine or blood pregnancy test for women of childbearing potential within 24 hours of first PEG IFN study medication administration
Able and willing to provide informed consent and abide by the requirements of the study

Exclusion criteria

Neutrophil count <1.5 x 109cells/L or platelet count <90 x 109cells/L
Co-infections with HIV, HAV, HCV, HDV or HEV
Women with ongoing pregnancy or breast feeding, or wishing to become pregnant during the study period
Prolonged and excessive alcohol intake (> 40g/day for men and > 30g/day for women)
Active intravenous drug abuse
History or current treatment with telbivudine
Treatment with immunomodulators (e.g. Interferon) for less than one year before study enrollment
Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) <=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
Serum concentrations of ceruloplasmin or alfa-antitrypsin consistent with an increased risk of metabolic disease
History or other evidence of chronic pulmonary disease associated with functional limitation
History of severe cardiac disease
History of the severe seizure disorder or current anticonvulsivant use
History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
History or other evidence of severe retinopathy
History of autoimmune disease or presence of a significant level of auto-antibodies
Renal insufficiency (creatinine clearance of < 50 ml/min according to the Cockroft and Gault equation), kidney transplant, hemodialysis
History of depression or uncontrolled psychiatric disorders
Subjects protected by law or not in a position to give consent
Patients with reproductive potential not willing to use an effective method of contraception.
Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in-situ cervical carcinoma)