Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2025-12-16 @ 8:12 PM
Study NCT ID:
NCT06155760
Status:
None
Last Update Posted:
2023-12-04 00:00:00
First Post:
2023-11-16 00:00:00
Brief Title:
Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences, India
Study Overview
Official Title:
Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis.
Status:
None
Status Verified Date:
2023-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
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 - 15 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 ie 45 in each group Further adding 10 drop out cases it was decided to enroll 100 patients ie 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 045 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 PTINR CXR PCT Urine RM CS Blood CS
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 005 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 ie Remission in severe alcoholic hepatitis
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 - 15 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 ie 45 in each group Further adding 10 drop out cases it was decided to enroll 100 patients ie 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 045 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 PTINR CXR PCT Urine RM CS Blood CS
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 005 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 ie Remission in severe alcoholic hepatitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None