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Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

This study is not yet open for participant recruitment.
Verified May 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Gao zhiliang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01599130
First received: May 8, 2012
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.


Condition Intervention
Hepatitis B
 Drug: Entecavir
Drug: Peginterferon alfa-2a

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • HBeAg sericonversion rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HBeAg loss rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • HBeAg quantification dynamic change [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • HBsAg loss rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • HBsAg seroconversion rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • HBsAg quantification dynamic change [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • ALT normalization rate [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: entecavir
patients continue to use entecavir
 Drug: Entecavir
entecavir 0.5mg per day
Other Name: Baraclude
Experimental: peg-interferon
patients switch to sequential peg-interferon α-2a
 Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180ug per week
Other Name: Pagasys

Detailed Description:

For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 50 years old
  • HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
  • Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria:

  • Pregnant women
  • Decompensated liver disease
  • Combination infection of HCV, HAV, or HEV
  • Combination infection of HIV
  • Any contraindication of interferon α
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599130

Locations
China, Guangdong
The Third Affliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Yufeng Zhang, master     +862085253333     zhanlianh@163.com    
Contact     +862085253333        
Principal Investigator: Zhiliang Gao, doctor            
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zhiliang Gao The Third Affliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Gao zhiliang, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01599130     History of Changes
Other Study ID Numbers: Zhangyufeng
Study First Received: May 8, 2012
Last Updated: May 14, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Hepatitis B
sequential peg-interferon-2a to entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Interferons
Peginterferon alfa-2a
Interferon-alpha
Entecavir
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013