A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatment||peginterferon alfa 2a|
|Sponsor||The Second Affiliated Hospital of Chongqing Medical University|
|Start date||October 2011|
|End date||June 2016|
|Trial size||300 participants|
|Trial identifier||NCT01464281, ML27928|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
determine the response rate (HBsAg clearance at Week 48 and 96)
time frame: 1 year
HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF
time frame: 1 year
Male or female participants from 18 years up to 65 years old.
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)
|Official title||A Randomized, Multicenter Study Evaluating HBsAg Clearance in CHB Patients Achieving HBeAg Loss and HBV DNA <200copies/ml on Treatment With Nucleotide Analogues and Switched to Peginterferon Alfa-2a|
|Principal investigator||Hong Ren|
|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).|
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