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Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pegylated Interferon-alpha2a
Thymosin alpha1 & Pegylated Interferon-alpha2a
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring chronic hepatitis B, pegylated interferon, thymosin alpha

Eligibility Criteria

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

Inclusion Criteria: HBsAg positive and anti-HBs negative for more than 6 months HBeAg positive HBV DNA titer more than 100,000 IU/mL serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value Exclusion Criteria: the history of antiviral therapy for chronic hepatitis B within the recent 6 months HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab + the sign of decompensated liver disease the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease pregnant or lactating woman neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3 serum creatinine more than 1.5 times upper normal limit value the sign of alcoholic or drug addiction within the recent 1 year the history of psychotic disorder especially like depression immunologically mediated disease the history of esophageal varix the history of severe heart disease or respiratory disease the history of severe epilepsy or current use of antiepileptic drug the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20% the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid the history of major organ transplantation the history of medically uncontrolled thyroid disease the history or sign of severe retinopathy

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Pegylated Interferon-alpha2a

Thymosin alpha1 & Pegylated Interferon-alpha2a

Outcomes

Primary Outcome Measures

HBeAg seroconversion, HBV DNA titer<20,000 IU/mL

Secondary Outcome Measures

Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs

Full Information

First Posted
February 13, 2006
Last Updated
July 20, 2011
Sponsor
Seoul National University Hospital
Collaborators
Roche Pharma AG, SciClone Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00291616
Brief Title
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
Official Title
A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Roche Pharma AG, SciClone Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Detailed Description
Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration. In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pegylated Interferon-alpha2a
Arm Title
2
Arm Type
Active Comparator
Arm Description
Thymosin alpha1 & Pegylated Interferon-alpha2a
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon-alpha2a
Intervention Description
180 microgram s.c. injection weekly
Intervention Type
Drug
Intervention Name(s)
Thymosin alpha1 & Pegylated Interferon-alpha2a
Intervention Description
Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week
Primary Outcome Measure Information:
Title
HBeAg seroconversion, HBV DNA titer<20,000 IU/mL
Time Frame
48 week and 96 week
Secondary Outcome Measure Information:
Title
Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs
Time Frame
48 week and 96 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HBsAg positive and anti-HBs negative for more than 6 months HBeAg positive HBV DNA titer more than 100,000 IU/mL serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value Exclusion Criteria: the history of antiviral therapy for chronic hepatitis B within the recent 6 months HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab + the sign of decompensated liver disease the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease pregnant or lactating woman neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3 serum creatinine more than 1.5 times upper normal limit value the sign of alcoholic or drug addiction within the recent 1 year the history of psychotic disorder especially like depression immunologically mediated disease the history of esophageal varix the history of severe heart disease or respiratory disease the history of severe epilepsy or current use of antiepileptic drug the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20% the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid the history of major organ transplantation the history of medically uncontrolled thyroid disease the history or sign of severe retinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung H Yoon, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Chongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

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