Alcoholic HepatitisNCT04066179
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
A study testing Gcsf and Prednisolone in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Gcsf and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndia
- Study dates
- 7 Sep 2019to 27 Feb 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
- Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
Who cannot join
- Presence of active infections
- Acute Gastrointestinal bleed
- Hepatorenal syndrome
- Patient unwilling
- Discriminant Function >90
- Autoimmune hepatitis
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- Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
- Pregnancy
- Hemophagocytic lymphohistiocytosis (HLH)
- Hb<8 and baseline White Blood Cell>25000
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ajay Mishra, MD, 01146300000, ajaymishrapandit@gmail.com
About this study
Official title: Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Gcsf, Prednisolone
- 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
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
PrednisoloneDrug
Prednisolone 40 mg for initial 7 days
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone+G-CSF | Experimental | Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days Receives: Drug: Gcsf; Drug: Prednisolone |
| Prednisolone | Active comparator | Prednisolone 40 mg/day for 7 days Receives: Drug: Prednisolone |
| Granulocytes-Colony Stimulating Factor | Experimental | Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days Receives: Drug: Gcsf |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in Survival at 90 days in all the groups.
Measured: 90 days
Secondary outcomes (4)
Improvement in CTP (Child-Pugh Score) in all the groups.
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Measured: Day 28
Improvement in CTP (Child-Pugh Score) in all the groups.
CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst.
Measured: Day 180
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.
Measured: Day 28
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start7 Sep 2019 (estimated)
- Primary completion27 Feb 2021 (estimated)
- Study completion27 Feb 2021 (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.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066179
- Sponsor's protocol ID
- ILBS-AH-03
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04066179
- Acronym / sponsor ID
- ILBS-AH-03
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Sep 2019 (estimated)
- Primary completion
- 27 Feb 2021 (estimated)
- Study completion
- 27 Feb 2021 (estimated)
- First posted
- 26 Aug 2019 (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.
The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prednisolone+G-CSF | Experimental | Drug: Gcsf, Drug: PrednisolonePrednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days |
| Prednisolone | Active comparator | Drug: PrednisolonePrednisolone 40 mg/day for 7 days |
| Granulocytes-Colony Stimulating Factor | Experimental | Drug: GcsfGranulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
Key exclusion criteria (10 listed)
- Presence of active infections
- Acute Gastrointestinal bleed
- Hepatorenal syndrome
- Patient unwilling
- Discriminant Function >90
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 |
|---|---|---|
| GcsfGranulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days | Drug | Granulocytes-Colony Stimulating Factor, Prednisolone+G-CSF |
| PrednisolonePrednisolone 40 mg for initial 7 days | Drug | Prednisolone, Prednisolone+G-CSF |
Primary outcome
increase in Survival at 90 days in all the groups.
Time frame: 90 days
4 secondary outcomes
Improvement in CTP (Child-Pugh Score) in all the groups.
Time frame: Day 28
Improvement in CTP (Child-Pugh Score) in all the groups.
Time frame: Day 180
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Time frame: Day 28
Improvement in MELD (Model for End Stage Liver Disease) in all the groups.
Time frame: Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- 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 study testing Gcsf and Prednisolone in people with Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India 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 1 inclusion and 10 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 9 Sep 2019. 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.
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 Dr Ajay Mishra, MD (01146300000, ajaymishrapandit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in Survival at 90 days in all the groups. (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 9 Sep 2019.