Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Chulalongkorn University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01243281
First Posted: November 18, 2010
Last Update Posted: June 28, 2011
Information provided by:
Chulalongkorn University
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Purpose
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
| Condition | Intervention |
|---|---|
| Chronic Hepatitis B | Drug: PEG-IFN and entecavir |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chulalongkorn University:
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 [ Time Frame: 24 weeks post treatment ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 126 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: drug combination |
Drug: PEG-IFN and entecavir
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.
Other Names:
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Eligibility
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01243281
Contacts
| Contact: Pisit Tangkijvanich, M.D. | +662-256-4482 | pisittkvn@yahoo.com |
Locations
| Thailand | |
| Faculty of Medicine, Chulalongkorn University | Recruiting |
| Bangkok, Thailand, 10330 | |
| Contact: Pisit Tangkijvanich, M.D. +662-256-4482 pisittkvn@yahoo.com | |
| Principal Investigator: Pisit Tangkijvanich, M.D. | |
Sponsors and Collaborators
Chulalongkorn University
Investigators
| Principal Investigator: | Pisit Tangkijvanich, M.D. | Chulalongkorn University |
More Information
| Responsible Party: | Dr. Pisit Tangkijvanich, Faculty of Medicine, Chulalongkorn University |
| ClinicalTrials.gov Identifier: | NCT01243281 History of Changes |
| Other Study ID Numbers: |
Biochem2010/01 |
| First Submitted: | November 17, 2010 |
| First Posted: | November 18, 2010 |
| Last Update Posted: | June 28, 2011 |
| Last Verified: | June 2011 |
Keywords provided by Chulalongkorn University:
|
hepatitis B HBeAg pegylated interferon entecavir |
Additional relevant MeSH terms:
|
Hepatitis 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 Interferons Interferon-alpha Entecavir Peginterferon alfa-2b Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |