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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses) |
|
| G-CSF | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Survival of subjects in both group | 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients | Change in child score at 4 week and 12 weeks compared to baseline in both groups. | 4 weeks and 12 weeks |
| Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients |
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Inclusion Criteria:
- Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30664267 | Derived | Shasthry SM, Sharma MK, Shasthry V, Pande A, Sarin SK. Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial. Hepatology. 2019 Sep;70(3):802-811. doi: 10.1002/hep.30516. Epub 2019 Mar 25. |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Placebo | Drug | Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses) |
|
Change in MELD score at 4 week and 12 weeks compared to baseline in both groups |
| 4 weeks and 12 weeks |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |