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Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
PEG-IFN and entecavir
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring hepatitis B, HBeAg, pegylated interferon, entecavir

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18 to 65 years of age
  • Patients with HBeAg-negative chronic hepatitis B
  • Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
  • Serum HBV DNA levels ≥ 2,000 IU/mL at screening
  • Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
  • No signs or symptoms of advanced liver disease
  • Patient has had a liver biopsy within 1 year of screening

Exclusion Criteria:

  • Patient had previous treatment with IFN, peg-IFN, and/or entecavir
  • Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
  • Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
  • Patients with liver cancer
  • Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
  • Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
  • Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug

Sites / Locations

  • Faculty of Medicine, Chulalongkorn UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

drug combination

Arm Description

Outcomes

Primary Outcome Measures

To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B

Secondary Outcome Measures

To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment

Full Information

First Posted
November 17, 2010
Last Updated
June 26, 2011
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01243281
Brief Title
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
Official Title
A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
hepatitis B, HBeAg, pegylated interferon, entecavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug combination
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PEG-IFN and entecavir
Other Intervention Name(s)
pegintron, baraclude
Intervention Description
The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.
Primary Outcome Measure Information:
Title
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
Time Frame
24 weeks post treatment
Secondary Outcome Measure Information:
Title
To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment
Time Frame
24 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 65 years of age Patients with HBeAg-negative chronic hepatitis B Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg Serum HBV DNA levels ≥ 2,000 IU/mL at screening Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN} No signs or symptoms of advanced liver disease Patient has had a liver biopsy within 1 year of screening Exclusion Criteria: Patient had previous treatment with IFN, peg-IFN, and/or entecavir Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus Patients with liver cancer Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment. Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pisit Tangkijvanich, M.D.
Phone
+662-256-4482
Email
pisittkvn@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pisit Tangkijvanich, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pisit Tangkijvanich, M.D.
Phone
+662-256-4482
Email
pisittkvn@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pisit Tangkijvanich, M.D.

12. IPD Sharing Statement

Learn more about this trial

Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

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