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

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ClinicalTrials.gov Identifier: NCT03164889
Recruitment Status : Unknown
Verified January 2017 by Beijing 302 Hospital.
Recruitment status was:  Recruiting
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Granulocyte Macrophage-colony Stimulating Factor Drug: Entecavir Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

Locations
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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
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Study Director: Ping Zhao, Director 302 Military Hospital, Beijing, China

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Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03164889     History of Changes
Other Study ID Numbers: 首发2014-2-5033
First Posted: May 24, 2017    Key Record Dates
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:
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Hepatitis B
Hepatitis B, Chronic
Sargramostim
Hepatitis A
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Entecavir
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents