Alcoholic HepatitisPhase 4NCT03703674
GCSF in Alcoholic Hepatitis
A Phase 4 study testing GCSF in people with Alcoholic Hepatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- GCSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 19 Nov 2017to 18 Nov 2020
- Phase
- Phase 4
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholic hepatitis patients:
- More than 10 years of heavy alcohol consumption (mean intake ≈ 100 g/day).
- Elevated aspartate aminotransferase level (but <500 IU per millilitre) and Ratio ofAST/ALT≥2 times
- Elevated serum total bilirubin level ≥ 5 mgdL (86 μmol/L)
- Elevated INR(≥1.5) and
- Neutrophilia. Patient with Maddrey's DF of ≥ 32 will be included in the study, with or without biopsy.
Who cannot join
- 1. Age < 18 and > 75 years 2. Hepatocellular carcinoma or portal vein thrombosis 3. Refusal to participate in the study 4. Serum creatinine>1.0 mg% 5. Hepatic encephalopathy- grade 3 or 4 6. Upper gastrointestinal bleed in last ten days 7. Uncontrolled bacterial infection 8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency 9. Pregnancy 10. Glucocorticoid treatment 11. Significant co-morbidity 12. Previous known hypersensitivity to G-CSF
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Virendra Singh, 7087009338, virendrasingh100@hotmail.com
About this study
Official title: Granulocyte Colony Stimulating Factor in Alcoholic Hepatitis
Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate.
G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF.
Therefore we plan to study the safety and efficacy of G-CSF in the patients with alcoholic hepatitis.
Read the detailed description
Detailed Description:
Patients with severe alcoholic hepatitis, admitted to Department of Hepatology PGIMER, Chandigarh will be included in the study.
METHODS
This will be an open label trial. A randomization code is generated by random number table. The patients will be randomized to receive standard medical therapy (SMT) only as control and therapy of G-CSF as case. There will be one control and one case as below:
- SMT (control) 2) G-CSF (case): G-CSF 5 mcg/kg every 12 hourly for consecutive 5 days This will be a single time therapy. Patients will be admitted in the department of hepatology and will be assessed everyday clinically as well as by laboratory tests during therapy to assess safety and effects of treatment.
- Total leukocytes count will be assessed daily.
- Circulating CD 34 positive cells will be measured on day 0 and 6 of G-CSF therapy.
- In addition, ultrasonography will be performed at day 1 and 6 in order to evaluate difference in spleen size and portal vein flow.
- Biochemical, coagulation, and hematological parameters (Liver function tests, Renal Function Tests, Prothrombin Time, International Normalised Ratio, etc.) will be monitored periodically, daily for 1 week, then weekly for 1month and monthly for three month.
All patients will be followed at weekly interval for 1 month and then monthly for 3 months.
Outcome:
Primary Objectives:
Survival at 3 months
Secondary Objectives:
Mobilisation of CD34 positive cells in peripheral blood.Clinical/biochemical improvement in liver function profile.Improvement in prognostic scores-Maddrey's Discriminant function, MELD score, and Child score.
Safety and efficacy of G-CSF in alcoholic hepatitis
- Conditions
- Alcoholic Hepatitis
- Being tested
- GCSF
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCSFDrug
Granulocyte-colony stimulating factors (G-CSF)
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Therapy | Active comparator | Drug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated. Receives: Drug: GCSF |
| G-CSF + Standard Medical Therapy | Experimental | Drug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated.
Drug: G-CSF G-CSF- 5 μg/Kg s.c every 12 hours for 5 consecutive days Receives: Drug: GCSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 3 months
Measured: 90 DAYS
Secondary outcomes (5)
Mobilisation of CD34 positive cells in peripheral blood.
Measured: 6 DAYS
Improvement in MELD score
Measured: 90 DAYS
Improvement in Maddrey's Discriminant Function.
Measured: 90 Days
Improvement in Child Turcotte Pugh score.
Measured: 90 Days
Number of participants with treatment-related adverse events in the different groups.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start19 Nov 2017
- Primary completion18 Nov 2020 (estimated)
- Study completion18 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Virendra Singh, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703674
- Sponsor's protocol ID
- GCSF IN ALCOHOLIC HEPATITIS
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2018
- Last updated
- 12 Oct 2018
- 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 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte Colony Stimulating Factor in Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT03703674
- Acronym / sponsor ID
- GCSF IN ALCOHOLIC HEPATITIS
- Conditions
- Alcoholic Hepatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 19 Nov 2017 (actual)
- Primary completion
- 18 Nov 2020 (estimated)
- Study completion
- 18 Nov 2020 (estimated)
- First posted
- 12 Oct 2018 (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.
Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate.
G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF.
Therefore we plan to study the safety and efficacy of G-CSF in the patients with alcoholic hepatitis.
Detailed description
Detailed Description:
Patients with severe alcoholic hepatitis, admitted to Department of Hepatology PGIMER, Chandigarh will be included in the study.
METHODS
This will be an open label trial. A randomization code is generated by random number table. The patients will be randomized to receive standard medical therapy (SMT) only as control and therapy of G-CSF as case. There will be one control and one case as below:
- SMT (control) 2) G-CSF (case): G-CSF 5 mcg/kg every 12 hourly for consecutive 5 days This will be a single time therapy. Patients will be admitted in the department of hepatology and will be assessed everyday clinically as well as by laboratory tests during therapy to assess safety and effects of treatment.
- Total leukocytes count will be assessed daily.
- Circulating CD 34 positive cells will be measured on day 0 and 6 of G-CSF therapy.
- In addition, ultrasonography will be performed at day 1 and 6 in order to evaluate difference in spleen size and portal vein flow.
- Biochemical, coagulation, and hematological parameters (Liver function tests, Renal Function Tests, Prothrombin Time, International Normalised Ratio, etc.) will be monitored periodically, daily for 1 week, then weekly for 1month and monthly for three month.
All patients will be followed at weekly interval for 1 month and then monthly for 3 months.
Outcome:
Primary Objectives:
Survival at 3 months
Secondary Objectives:
Mobilisation of CD34 positive cells in peripheral blood.Clinical/biochemical improvement in liver function profile.Improvement in prognostic scores-Maddrey's Discriminant function, MELD score, and Child score.
Safety and efficacy of G-CSF in alcoholic hepatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Therapy | Active comparator | Drug: GCSFDrug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated. |
| G-CSF + Standard Medical Therapy | Experimental | Drug: GCSFDrug: standard medical therapy Standard medical therapy involves primary treatment and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated. Drug: G-CSF G-CSF- 5 μg/Kg s.c every 12 hours for 5 consecutive days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Alcoholic hepatitis patients:
Key exclusion criteria (1 listed)
- 1. Age < 18 and > 75 years 2. Hepatocellular carcinoma or portal vein thrombosis 3. Refusal to participate in the study 4. Serum creatinine>1.0 mg% 5. Hepatic encephalopathy- grade 3 or 4 6. Upper gastrointestinal bleed in last ten days 7. Uncontrolled bacterial infection 8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency 9. Pregnancy 10. Glucocorticoid treatment 11. Significant co-morbidity 12. Previous known hypersensitivity to G-CSF
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 |
|---|---|---|
| GCSFGranulocyte-colony stimulating factors (G-CSF) | Drug | G-CSF + Standard Medical Therapy, Standard Medical Therapy |
Primary outcome
Survival at 3 months
Time frame: 90 DAYS
5 secondary outcomes
Mobilisation of CD34 positive cells in peripheral blood.
Time frame: 6 DAYS
Improvement in MELD score
Time frame: 90 DAYS
Improvement in Maddrey's Discriminant Function.
Time frame: 90 Days
Improvement in Child Turcotte Pugh score.
Time frame: 90 Days
Number of participants with treatment-related adverse events in the different groups.
Time frame: 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GCSF in people with Alcoholic Hepatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virendra Singh, DM (7087009338, virendrasingh100@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 3 months (time frame: 90 DAYS). 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 12 Oct 2018.