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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291616
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : July 21, 2011
Roche Pharma AG
SciClone Pharmaceuticals
Information provided by:
Seoul National University Hospital

Brief Summary:
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Pegylated Interferon-alpha2a Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Pegylated Interferon-alpha2a
Drug: Pegylated Interferon-alpha2a
180 microgram s.c. injection weekly
Active Comparator: 2
Thymosin alpha1 & Pegylated Interferon-alpha2a
Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a
Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week

Primary Outcome Measures :
  1. HBeAg seroconversion, HBV DNA titer<20,000 IU/mL [ Time Frame: 48 week and 96 week ]

Secondary Outcome Measures :
  1. Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs [ Time Frame: 48 week and 96 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00291616

Korea, Republic of
Seoul National University Hospital
Seoul, Chongno-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Roche Pharma AG
SciClone Pharmaceuticals
Principal Investigator: Jung H Yoon, M.D. Seoul National University Hospital

Responsible Party: Won Kim, Seoul National University Hospital Identifier: NCT00291616     History of Changes
Other Study ID Numbers: 12-05-008
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
chronic hepatitis B, pegylated interferon, thymosin alpha

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic