Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243281
• Other study ID #: Biochem2010/01
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2010
• Last updated: June 26, 2011
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2011
• Source: Chulalongkorn University
• Contact: Pisit Tangkijvanich, M.D.
• Phone: +662-256-4482
• Email: pisittkvn[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 weeks post treatment	Yes
Secondary	To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment		24 weeks post treatment	No