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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hong Ren, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01464281
First received: October 19, 2011
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Chronic Hepatitis B
Drug: Peginterferon alfa 2a

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • determine the response rate (HBsAg clearance at Week 48 and 96) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 300
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464281

Locations
China, Chongqing
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400010
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
Principal Investigator: Hong Ren The 2nd affiliated Hospital of Chongqing Medical University
  More Information

No publications provided

Responsible Party: Hong Ren, Principal Investigator, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01464281     History of Changes
Other Study ID Numbers: ML27928
Study First Received: October 19, 2011
Last Updated: November 1, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
nucleoside
peginterferon alfa-2a

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014