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

NCT ID: NCT00291616

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-08-31

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pegylated Interferon-alpha2a

Group Type: ACTIVE_COMPARATOR

Pegylated Interferon-alpha2a

Intervention Type: DRUG

180 microgram s.c. injection weekly

2

Thymosin alpha1 \& Pegylated Interferon-alpha2a

Group Type: ACTIVE_COMPARATOR

Thymosin alpha1 & Pegylated Interferon-alpha2a

Intervention Type: DRUG

Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week

Interventions

Pegylated Interferon-alpha2a

180 microgram s.c. injection weekly

Intervention Type: DRUG

Thymosin alpha1 & Pegylated Interferon-alpha2a

Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

SciClone Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

Jung H Yoon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Countries

South Korea

Other Identifiers

12-05-008

Identifier Type: -

Identifier Source: org_study_id