Trial record 63 of 512 for:    hepatitis b | Open Studies

Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Beijing Ditan Hospital
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT02362490
First received: February 9, 2015
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

Condition Intervention Phase
Chronic Hepatitis B
Drug: peginterferon alpha 2a
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HBsAg Clearance of Peginterferon Treatment in Patients Who Had Chronic Hepatitis B and Were on the Treatment of Nucleoside(Acid) Analogues

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • rate of HBsAg loss [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    the effects of peginterferon alpha 2a will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 72 week treatment,compared control group.


Secondary Outcome Measures:
  • decline of HBsAg level [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    secondary outcome was evaluated by the decline of HBsAg level after 72 weeks of peginterferon alpha 2a treatment compared with control group.


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peginterferon alpha 2a
in this group, patients who were on treatment of Nucleoside (Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will switch to treatment of peginterferon alpha 2a for 72 week.
Drug: peginterferon alpha 2a
in this group,patients will receive 180 ug of peginterferon alpha 2a injection weekly for 72 weeks
Other Name: PEG-IFN a-2a
No Intervention: control group
in this group, patients who were on treatment of Nucleoside(Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will be continue to treatment of Nucleoside(Acid) Analogues for 72 week.

Detailed Description:
In this trial, patients who were CHB and treated with NA more than 6 months, still on the treatment and achieved HBsAg level ≤250 IU/ml with HBV DNA undetectable will be randomized enrolled into group A (Intervention group), in which patients switch to interferon therapy for 72 weeks, group B(control group), patients continue treated with NA for 72 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 interferon treatment were devalued by the rate of HBsAg clearance and decline of HBsAg levels on the 72 weeks of interferon treatment compared with control group.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who were chronic hepatitis B and had achieved HBsAg level ≤250 IU/ml on treatment of Nucleoside (acid) Analogues

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02362490

Contacts
Contact: Yao Xie, MD 8610-84322489 xieyao00120184@sina.com

Locations
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

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02362490     History of Changes
Other Study ID Numbers: DTXY004 
Study First Received: February 9, 2015
Last Updated: August 17, 2016
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Ditan Hospital:
chronic hepatitis B
interferon
Nucleotide analogues
HBsAg

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

ClinicalTrials.gov processed this record on August 29, 2016