Severe Alcoholic HepatitisNCT06155760
Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis
A study testing Prednisolone and Standard Medical therapy in people with Severe Alcoholic Hepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Alcoholic Hepatitis
- What is being tested?
- Prednisolone and Standard Medical therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 25 Nov 2023to 27 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persistence of mDF > 32 at day 28 of steroids.
Who cannot join
- Active infection
- Uncontrolled sugars
- No consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Ravi Nishad, MD, 01146300000, ravinishad.422@gmail.com
About this study
Official title: Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis.
Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Prednisolone (40 mg/day) given orally should be considered to improve 28-day mortality in patients with severe AH. Abstinence is key to long-term survival.
According to current protocol, we discontinue the treatment after 28 days but only 15 % patient is achieving the DF < 32 after 28 days of treatment.
The aim of this study is to evaluate the role of extended low dose prednisolone (10mg) in achieving remission by day-90 in steroid responsive severe alcoholic hepatitis.
Read the detailed description
Study Design- Single center, Open label, Randomized controlled trial
- According to current protocol, we discontinue the treatment after 28 days, it improve the mortality rate in severe alcoholic patient with mDF score of more than 32 but only 15% patient is achieving the mDF < 32 after 28 days of treatment.
- Abstinence is key to long-term survival. No data is available in giving steroids for more than 28days going to improve clinical or biochemical parameter of the patient.
Methodology:
- Study population: All patients aged ≥ 18 years and ≤ 60 years admitted in Institute of Liver and Biliary Sciences, New Delhi with Severe Alcoholic hepatitis mDF of more than 32 days after 28days of steroid therapy and are giving written consent for participation in the study. Option of LDLT, Plasma exchange, FMT, GM- CSF given to patient with DF more than 32 after 28 days of steroid therapy and these patients are excluded from the study.
- Study period - 1.5 years after IEC approval
- Sample size - We are enrolling 150 patients.- Assuming that the response rate is 50% in prednisolone + SMT group and 20% in only SMT group. With alpha- 5% and power of 80, we need to enroll - 90 cases i.e, 45 in each group. Further adding 10% drop out cases, it was decided to enroll 100 patients i.e, 50 in each group. Allocation will be done randomly by block randomization panel by block size of 10. Further assuming that DF > 32 will be in 80% cases we need to enroll 125 cases. Further 80% will have lille score < 0.45, so it is to decide to enroll 150 cases.
- Intervention - Extended steroid group: 10mg of prednisolone plus standard medical therapy for 60 days.
- Placebo group: Standard treatment plus placebo that the patient would receive included in the trial.
- SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision
- Monitoring and assessment:
- Investigations - Tests performed on Day 0, 4, 7, 28, 60 and 90.
- Routine: CBC, RFT, LFT, PT/INR, CXR, PCT, Urine R/M \& C/S, Blood C/S,
- Blood sugar- fasting \& PP.
- Statistical Analysis: The data will be represented as mean ± SD. The categorical data will be analysed using Chi-square test. The continuous data will be analysed by student T test, or Mann-Whitney test, whichever is applicable. Besides this, Cox regression will be applied to analyse the variables. For all tests, p≤ 0.05 will be considered statistically significant
- Adverse effects
- New onset Diabetes, risk of infection
- Stopping rule
- Discontinuation of steroids (variceal bleed, infections, uncontrolled sugars, new onset AKI)
- Death
- Liver transplantation
- Lapse or relapse of alcohol consumption
Expected outcome of the project:
- Improvement in the mDF score (<32) i.e. Remission in severe alcoholic hepatitis.
- Conditions
- Severe Alcoholic Hepatitis
- Being tested
- Prednisolone, Standard Medical therapy, Placebo
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
10mg of prednisolone plus standard medical therapy for 60 days
Standard Medical therapyOther
IV Albumin, Diuretics, Multi vitamins as per clinicians decision
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Extended Steroid Therapy | Experimental | 10mg of prednisolone plus standard medical therapy for 60 days. SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision Receives: Drug: Prednisolone; Other: Standard Medical therapy |
| Placebo group | Active comparator | Standard treatment plus placebo that the patient would receive included in the trial.
SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision Receives: Other: Standard Medical therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMT
Measured: 90 days
Secondary outcomes (4)
Changes in the liver disease severity parameters like CTP, MELD-Na, DF, by extending the low dose steroids by 2 months in the study group compared with the control group.
Measured: 90 days
Number of patients with SAH achieving 90 day transplant-free survival between the two groups.
Measured: 90 day, 180 day
New onset infections, diabetes
To check new onset of infection as suspected by clinical presentation and by laboratory tests such as procalcitonin, Urine Culture, Blood Culture, chest X- Ray and Ascitic fluid analysis. And for measuring diabetes onset regular fasting and post prandial sugar charting on weekly basis throughout the study period.
Measured: 90 days
90 day readmission rates
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 posted4 Dec 2023
- Study start25 Nov 2023 (estimated)
- Primary completion27 Feb 2025 (estimated)
- Study completion27 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 150 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
- NCT06155760
- Sponsor's protocol ID
- ILBS-ALD-03
- Status last verified
- Oct 2023
- First submitted
- 16 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis.
- ClinicalTrials.gov ID
- NCT06155760
- Acronym / sponsor ID
- ILBS-ALD-03
- Conditions
- Severe Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 4 Dec 2023 (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.
Severity of alcoholic hepatitis is defined by Maddrey's discriminant function, value of 32 or higher indicates severe alcoholic hepatitis that carries an adverse prognosis with one month mortality of 30%-50%. Prednisolone (40 mg/day) given orally should be considered to improve 28-day mortality in patients with severe AH. Abstinence is key to long-term survival.
According to current protocol, we discontinue the treatment after 28 days but only 15 % patient is achieving the DF < 32 after 28 days of treatment.
The aim of this study is to evaluate the role of extended low dose prednisolone (10mg) in achieving remission by day-90 in steroid responsive severe alcoholic hepatitis.
Detailed description
Study Design- Single center, Open label, Randomized controlled trial
- According to current protocol, we discontinue the treatment after 28 days, it improve the mortality rate in severe alcoholic patient with mDF score of more than 32 but only 15% patient is achieving the mDF < 32 after 28 days of treatment.
- Abstinence is key to long-term survival. No data is available in giving steroids for more than 28days going to improve clinical or biochemical parameter of the patient.
Methodology:
- Study population: All patients aged ≥ 18 years and ≤ 60 years admitted in Institute of Liver and Biliary Sciences, New Delhi with Severe Alcoholic hepatitis mDF of more than 32 days after 28days of steroid therapy and are giving written consent for participation in the study. Option of LDLT, Plasma exchange, FMT, GM- CSF given to patient with DF more than 32 after 28 days of steroid therapy and these patients are excluded from the study.
- Study period - 1.5 years after IEC approval
- Sample size - We are enrolling 150 patients.- Assuming that the response rate is 50% in prednisolone + SMT group and 20% in only SMT group. With alpha- 5% and power of 80, we need to enroll - 90 cases i.e, 45 in each group. Further adding 10% drop out cases, it was decided to enroll 100 patients i.e, 50 in each group. Allocation will be done randomly by block randomization panel by block size of 10. Further assuming that DF > 32 will be in 80% cases we need to enroll 125 cases. Further 80% will have lille score < 0.45, so it is to decide to enroll 150 cases.
- Intervention - Extended steroid group: 10mg of prednisolone plus standard medical therapy for 60 days.
- Placebo group: Standard treatment plus placebo that the patient would receive included in the trial.
- SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision
- Monitoring and assessment:
- Investigations - Tests performed on Day 0, 4, 7, 28, 60 and 90.
- Routine: CBC, RFT, LFT, PT/INR, CXR, PCT, Urine R/M \& C/S, Blood C/S,
- Blood sugar- fasting \& PP.
- Statistical Analysis: The data will be represented as mean ± SD. The categorical data will be analysed using Chi-square test. The continuous data will be analysed by student T test, or Mann-Whitney test, whichever is applicable. Besides this, Cox regression will be applied to analyse the variables. For all tests, p≤ 0.05 will be considered statistically significant
- Adverse effects
- New onset Diabetes, risk of infection
- Stopping rule
- Discontinuation of steroids (variceal bleed, infections, uncontrolled sugars, new onset AKI)
- Death
- Liver transplantation
- Lapse or relapse of alcohol consumption
Expected outcome of the project:
- Improvement in the mDF score (<32) i.e. Remission in severe alcoholic hepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Steroid Therapy | Experimental | Drug: Prednisolone, Other: Standard Medical therapy10mg of prednisolone plus standard medical therapy for 60 days. SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision |
| Placebo group | Active comparator | Other: Standard Medical therapy, Drug: PlaceboStandard treatment plus placebo that the patient would receive included in the trial. SMT- IV Albumin, Diuretics, Multi vitamins as per clinicians decision |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Persistence of mDF > 32 at day 28 of steroids.
Key exclusion criteria (3 listed)
- Active infection
- Uncontrolled sugars
- No consent
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 |
|---|---|---|
| Prednisolone10mg of prednisolone plus standard medical therapy for 60 days | Drug | Extended Steroid Therapy |
| Standard Medical therapyIV Albumin, Diuretics, Multi vitamins as per clinicians decision | Other | Extended Steroid Therapy, Placebo group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMT
Time frame: 90 days
4 secondary outcomes
Changes in the liver disease severity parameters like CTP, MELD-Na, DF, by extending the low dose steroids by 2 months in the study group compared with the control group.
Time frame: 90 days
Number of patients with SAH achieving 90 day transplant-free survival between the two groups.
Time frame: 90 day, 180 day
New onset infections, diabetes
Time frame: 90 days
90 day readmission rates
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 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH
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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 Prednisolone and Standard Medical therapy in people with Severe 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 3 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 4 Dec 2023. 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 Ravi Nishad, MD (01146300000, ravinishad.422@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMT (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 4 Dec 2023.