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

Purpose

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

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

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Interferon Interferon Alfa-2a Peginterferon Alfa-2a Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

HBeAg seroconversion, HBV DNA titer<20,000 IU/mL [ Time Frame: 48 week and 96 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs [ Time Frame: 48 week and 96 week ] [ Designated as safety issue: Yes ]

Enrollment:	52
Study Start Date:	December 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291616

Locations

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

Investigators

Principal Investigator:

Jung H Yoon, M.D.

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Won Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00291616 History of Changes
Other Study ID Numbers:	12-05-008
Study First Received:	February 13, 2006
Last Updated:	July 20, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

chronic hepatitis B, pegylated interferon, thymosin alpha

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Interferon-alpha

Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Thymalfasin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013