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

November 1, 2011 updated by: Hong Ren, The Second Affiliated Hospital of Chongqing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 48-week standard treatment
48-week standard treatment by Peginterferon alfa 2a 180µg/week
Drug: Peginterferon alfa 2a
Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
Active Comparator: 96-week prolonged treatment
96-week prolonged treatment by Peginterferon alfa 2a 180µg/week
Drug: Peginterferon alfa 2a
Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the response rate (HBsAg clearance at Week 48 and 96)
Time Frame: 1 year
To determine the response rate (HBsAg clearance at Week 48 and 96) in subjects who are being treated by NAs and achieved a combined response which consists of both HBeAg loss and HBV DNA <1000 copies/ml
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF
Time Frame: 1 year
  1. HBsAg loss at EOF
  2. Quantitative HBe/sAg reduction at every check point.
  3. HBeAg seroconversion at EOT and EOF
  4. HBV DNA changes over 48 or 96 weeks at every check points
  5. ALT normalization at EOT and EOF
  6. HBsAg seroconversion at EOT and EOF
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Hong Ren, The 2nd affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML27928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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