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Trial record 23 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients

This study is currently recruiting participants.
Verified January 2017 by Beijing 302 Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03164889
First Posted: May 24, 2017
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Beijing 302 Hospital
  Purpose
Previous studies indicated that Granulocyte Macrophage-colony Stimulating Factor (GM-CSF) could improve survival rate in patients with acute liver failure and obtain higher HBsAg seroconversion rate when in combination with peg-interferon for chronic hepatitis B (CHB) patients. In this study, investigators will study the clinical effect of entecavir (ETV) plus GM-CSF in patients with CHB compared to ETV monotherapy.

Condition Intervention
Hepatitis B, Chronic Drug: Granulocyte Macrophage-colony Stimulating Factor Drug: Entecavir

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Basic Research of Relationship Between Hepatitis B Virus Quasi-Species Evolution and Function of Natural Killer Cells With Antiviral Therapy Response in Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Beijing 302 Hospital:

Primary Outcome Measures:
  • Rate of HBsAg loss [ Time Frame: 48 weeks after therapy ]

Secondary Outcome Measures:
  • Rate of HBeAg loss [ Time Frame: 48 weeks after therapy ]
  • HBVDNA undetectable rate [ Time Frame: 48 weeks after therapy ]

Estimated Enrollment: 220
Actual Study Start Date: January 2017
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETV+GM-CSF
Entecavir (ETV) plus Granulocyte Macrophage-colony Stimulating Factor (GM-CSF). ETV was given 0.5mg/d, oral; GM-CSF was given 100ug, the 3th, 4th, 5th day at week1, 4, 12, 24, 48, subcutaneous injection.
Drug: Granulocyte Macrophage-colony Stimulating Factor
The intervention drug was used as an immunomodulator in order to improve rates of HBsAg loss and HBeAg loss.
Other Name: GM-CSF
Drug: Entecavir
Antiviral drug for hepatitis b virus (HBV)
Other Name: ETV
Active Comparator: ETV monotherapy
As standard antiviral therapy, Entecavir was given 0.5mg/d, oral.
Drug: Entecavir
Antiviral drug for hepatitis b virus (HBV)
Other Name: ETV

Detailed Description:
Antiviral treatment plays critical role in treatment of chronic HBV infection. Entecavir, an nucleos(t)ide analogs (NA) targeting the viral polymerase, is widely used in China as the first line drug in antiviral treatment for CHB patients. The sustained suppression of serum HBV DNA to undetectable level has been proven to be associated with the prevention of progression of liver disease and inhibition of the development of hepatocellular carcinoma. According to data published, a rate about 70% HBVDNA undetectable could be reached after 1 year therapy. However, the rate of HBsAg loss is very low about 0% to 1%. Granulocyte-macrophage colony-stimulating factor(GM-CSF) is an important cytokine for the generation and propagation of antigen-presenting cells and for priming a cellular immune response. It increases the production of macrophage precursors and, in turn,enhances the T-helper cell (Th cell)-mediated cytotoxicity and regulates the tumoricidal cytokines. Previous studies indicated that when combined with IFN in patients with chronic HBV infection, it increased the therapeutic efficacy of the latter. Recent studies showed that GM-CSF benefit patients with acute liver failure. In this study, entecavir (ETV) plus GM-CSF would be used in patients with CHB compared to ETV monotherapy. Primary objective of the study is to see if there is significant improvement in HBsAg loss, rates of HBeAg loss and HBV undetectable are also to be observed. Function of NK cell from the patients enrolled will be measured during the therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HBsAg positive for more than 6 months
  • HBeAg positive
  • ALT≥80U/L or inflammation score ≥2 of histological examination

Exclusion Criteria:

  • History of drug allergy to GM-CSF
  • coinfection with HCV, HIV, HAV, HEV
  • liver cirrhosis or CHILD score >7
  • diagnosis of hepatocellular carcinoma or AFP>100ng/ml
  • Allergic thrombocytopenic purpura
  Contacts and Locations
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): NCT03164889


Contacts
Contact: Ping Zhao, Director +8613910081668 zhaop9262@sina.com
Contact: Tao Yan, Physician +8613810221518 plahyt@163.com

Locations
China, Beijing
302 Military Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: Ping Zhao, Director    +8613910081668    zhaop9262@sina.com   
Contact: Tao Yan, Physician    +8613810221518    plahyt@163.com   
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
Study Director: Ping Zhao, Director 302 Military Hospital, Beijing, China
  More Information

Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03164889     History of Changes
Other Study ID Numbers: 首发2014-2-5033
First Submitted: November 15, 2016
First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Beijing 302 Hospital:
Chronic hepatitis B, antiviral treatment

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
Antiviral Agents
Entecavir
Anti-Infective Agents