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

Information source: The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Peginterferon alfa 2a (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: The Second Affiliated Hospital of Chongqing Medical University

Official(s) and/or principal investigator(s):
Hong Ren, Principal Investigator, Affiliation: The 2nd affiliated Hospital of Chongqing Medical University

Summary

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 180g/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180g/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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: determine the response rate (HBsAg clearance at Week 48 and 96)

Secondary outcome: HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF

Detailed 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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

The 2nd affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing 400010, China
Additional Information

Starting date: October 2011
Last updated: November 1, 2011

Page last updated: August 23, 2015

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