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

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ClinicalTrials.gov Identifier: NCT02368288
Recruitment Status : Unknown
Verified August 2016 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was:  Recruiting
First Posted : February 23, 2015
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Brief Summary:
The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with 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 withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

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

Detailed Description:
HBeAg positive patients with HBV DNA load ≥1000copies/ml after 6 months of peginterferon alpha 2a treatment will be enrolled randomized into two groups, in intervention group, patients will receive entecavir combine with peginterferon alpha 2a(PEG-IFN a-2a) treatment for 48 weeks and follow 24 weeks. Patients in control group will be continue treated with PEG-IFN a-2a for 48 weeks and followed 24 weeks. 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 the combined therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacies of Entecavir Add on Chronic Hepatitis B Patients With HBV DNA Load ≥1000 Copies/ml After 6 Months Treatment of Peginterferon Alpha 2a
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


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.
Drug: entecavir
in this group, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 week.

No Intervention: peginterferon alpha 2a
in this group, patients will be continue treated only with PEG-IFN a-2a for 48 weeks after enrolled.



Primary Outcome Measures :
  1. rate of HBeAg seroconversion [ Time Frame: 48 weeks ]
    HBeAg seroconversion defined as HBeAg loss with anti-HBe antibody positive was evaluated during weeks treatment period


Secondary Outcome Measures :
  1. rate of HBsAg loss [ Time Frame: 48 weeks ]
    HBsAg loss defined as HBsAg level ≤0.05 IU/ml after 48 week treatment



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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 positive patients with HBV DNA load ≥1000copies/ml after 6 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

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): NCT02368288


Contacts
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Contact: yao xie, MD 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

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Responsible Party: Yao Xie, liver disease center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02368288     History of Changes
Other Study ID Numbers: DTXY005
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitic B
peginterferon
HBsAg
entecavir
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Peginterferon alfa-2a
Interferon-alpha
Interferon alpha-2
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents