GCSF in Alcoholic Hepatitis

Phase 4

• Conditions: Health Condition 1: K701- Alcoholic hepatitis

• Registration Number: CTRI/2018/10/016030
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.More than 10 years of heavy alcohol consumption (mean intake â?? 100 g/day).

2.Elevated aspartate aminotransferase level (but <500 IU per millilitre) and Ratio ofAST/ALT>=2 times

3.Elevated serum total bilirubin level >= 5 mgdL (86 μmol/L)

4.Elevated INR(>=1.5) and

5. Neutrophilia patients with mDF >= 32 with or without biopsy

Exclusion Criteria

1.Age < 18 and > 75 years

2.Hepatocellular carcinoma or portal vein thrombosis

3.Refusal to participate in the study

4.4.Serum creatinine >1.0 mg%

5.Hepatic encephalopathy- grade 3 or 4

6.Upper gastrointestinal bleed in last ten days

7.Uncontrolled bacterial infection

8. HIV, Hepatitis B and Hepatitis C virus seropositivity, autoimmune Hepatitis, hemochromatosis, wilson disease and alpha 1 antitrypsin def.

9.Pregnancy

10.Glucocorticoid treatment

11.Significant co-morbidity

12.Previous known hypersensitivity to G-CSF

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures : <br/ ><br>1.Primary end point-Survival at the end of 90 days. <br/ ><br>Secondary Outcome Measures : <br/ ><br>1 mobilization of CD34+ cells in peripheral blood . <br/ ><br>2.Improvement in MELD score <br/ ><br>3.Number of participants with treatment-related adverse events in the different treatment groups. <br/ ><br>4.improvement in modified Discriminant Factor <br/ ><br>5.improvement in Child Turcotte Pugh score. <br/ ><br>Timepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcome <br/ ><br>1. Mobilization of CD34 positive cells in peripheral blood <br/ ><br>2, Improvement of MELD Score <br/ ><br>3, Number of participants with treatment related adverse events in the different groups <br/ ><br>4, Improvement in mDF <br/ ><br>5 Improvement in CTPTimepoint: 90 days