Severe Alcoholic Hepatitis
Conditions
Brief summary
After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score \[\>0.45\] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.
Interventions
DRUGG-CSF
G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.
DRUGPlacebo
Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\- Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.
Exclusion criteria
* Presence of active infections * Acute GI bleed * Hepatorenal syndrome * Patient unwilling * DF\>120 * Autoimmune hepatitis * Hepatitis B, Hepatitis C, HIV cases * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Survival of subjects in both group | 4 weeks and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients | 4 weeks and 12 weeks | Change in child score at 4 week and 12 weeks compared to baseline in both groups. |
| Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients | 4 weeks and 12 weeks | Change in MELD score at 4 week and 12 weeks compared to baseline in both groups |
Countries
India
Outcome results
None listed