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Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

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ClinicalTrials.gov Identifier: NCT02365402
Recruitment Status : Unknown
Verified August 2016 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was:  Recruiting
First Posted : February 18, 2015
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Study Description
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Brief Summary:
The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Entecavir Phase 4

Detailed Description:
HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment would be randomize enrolled into two groups, in Interventional group, patients will receive entecavir combine with peginterferon alpha 2a treatment for 48 weeks and followed 24 weeks. Patients in control group will be continue treated only by peginterferon alpha 2a for 48 weeks and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during the treatment course. Parameters of Liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies of combined therapy were evaluated by the rate of sustained viral response after 48 weeks treatment and 24 weeks follow up compared with control group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacies of Entecavir Add on HBeAg Negative Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 3 Months of Peginterferon Alpha 2a Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arms and Interventions
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Arm Intervention/treatment
Experimental: entecavir with PEG-IFN a-2a
After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow up after treatment.
 Drug: Entecavir
After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow-up after treatment.
No Intervention: control group
In this group, patients will be continue treated only by PEG-IFN a-2a for 48 weeks after enrolled and receive 24 weeks of follow up.


Outcome Measures
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Primary Outcome Measures :
  1. rate of sustained virual response [ Time Frame: 72 weeks ]
    sustained viral response was defined as serum HBV DNA load was undetectable at the end of treatment and 24 weeks of follow-up.


Secondary Outcome Measures :
  1. rates of HBsAg loss during treatment course and at the end of follow-up [ Time Frame: 72 weeks ]
    HBsAg loss defined as HBsAg level ≤0.05 IU/ml


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HBeAg negative patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon a-2a treatment

Exclusion Criteria:

  • Active consumption of alcohol and/or drugs
  • Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
  • History of autoimmune hepatitis
  • Psychiatric disease
  • Evidence of neoplastic diseases of the liver
Contacts and Locations
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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): NCT02365402


Contacts
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Contact: yao Xie 8610-84322489 xieyao00120184@sina.com

Locations
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China, Beijing
Beijing Ditan hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, doctor    8613501093293    xieyao00120184@sina.com   
Principal Investigator: Yao Xie, doctor         
Sponsors and Collaborators
Beijing Ditan Hospital
More Information
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Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02365402    
Other Study ID Numbers: DTXY006
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
peginterferon
sustained viral response
entecavir
HBeAg
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents