Hepatitis B, ChronicNCT03164889
Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients
A study testing Granulocyte Macrophage-colony Stimulating Factor and Entecavir in people with Hepatitis B, Chronic, run by Beijing 302 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Granulocyte Macrophage-colony Stimulating Factor and Entecavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBsAg positive for more than 6 months
- HBeAg positive
- ALT≥80U/L or inflammation score ≥2 of histological examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Granulocyte Macrophage-colony Stimulating Factor, Entecavir
- Keywords
- Chronic hepatitis B, antiviral treatment
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Macrophage-colony Stimulating FactorDrug
Also called GM-CSF
The intervention drug was used as an immunomodulator in order to improve rates of HBsAg loss and HBeAg loss.
EntecavirDrug
Also called ETV
Antiviral drug for hepatitis b virus (HBV)
| Study group | Role | What they receive |
|---|---|---|
| ETV+GM-CSF | Experimental | 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. Receives: Drug: Granulocyte Macrophage-colony Stimulating Factor; Drug: Entecavir |
| ETV monotherapy | Active comparator | As standard antiviral therapy, Entecavir was given 0.5mg/d, oral. Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HBsAg loss
Measured: 48 weeks after therapy
Secondary outcomes (2)
Rate of HBeAg loss
Measured: 48 weeks after therapy
HBVDNA undetectable rate
Measured: 48 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startJan 2017
- Primary completion1 Jan 2018
- Study completion1 Dec 2021
Why it stopped: no enough participant can be enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Zhao, Director, Study director, 302 Military Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164889
- Sponsor's protocol ID
- 首发2014-2-5033
- Status last verified
- Jan 2017
- First submitted
- 15 Nov 2016
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03164889
- Acronym / sponsor ID
- 首发2014-2-5033
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic hepatitis B, antiviral treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no enough participant can be enrolled
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETV+GM-CSF | Experimental | Drug: Granulocyte Macrophage-colony Stimulating Factor, Drug: EntecavirEntecavir (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. |
| ETV monotherapy | Active comparator | Drug: EntecavirAs standard antiviral therapy, Entecavir was given 0.5mg/d, oral. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HBsAg positive for more than 6 months
- HBeAg positive
- ALT≥80U/L or inflammation score ≥2 of histological examination
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte Macrophage-colony Stimulating FactorAlso: GM-CSFThe intervention drug was used as an immunomodulator in order to improve rates of HBsAg loss and HBeAg loss. | Drug | ETV+GM-CSF |
| EntecavirAlso: ETVAntiviral drug for hepatitis b virus (HBV) | Drug | ETV monotherapy, ETV+GM-CSF |
Primary outcome
Rate of HBsAg loss
Time frame: 48 weeks after therapy
2 secondary outcomes
Rate of HBeAg loss
Time frame: 48 weeks after therapy
HBVDNA undetectable rate
Time frame: 48 weeks after therapy
Results and safety
The study was stopped early (reason given: no enough participant can be enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Zhao, Director study director
302 Military Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Granulocyte Macrophage-colony Stimulating Factor and Entecavir in people with Hepatitis B, Chronic, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: no enough participant can be enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HBsAg loss (time frame: 48 weeks after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.