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GCSF in Alcoholic Hepatitis

Granulocyte Colony Stimulating Factor in alcoholic hepatitis - GCSF in AH

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016030
Enrollment
100
Registered
2018-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K701- Alcoholic hepatitis

Interventions

Intervention1: GCSF Group in Alcoholic Hepatitis: GCSF Group standard medical therapy plus G-CSF- 5μg/Kg s.c every 12 hours for 5 consecutive days Control Intervention1: Standard medical therapy in A

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. More than 10 years of heavy alcohol consumption (mean intake â?? 100 g/day). 2. Elevated aspartate aminotransferase level (but =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

Exclusion criteria: 1. Age 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary outcome 1. Mobilization of CD34 positive cells in peripheral blood 2, Improvement of MELD Score 3, Number of participants with treatment related adverse events in the different groups 4, Improvement in mDF 5 Improvement in CTPTimepoint: 90 days—

Countries

India

Contacts

Public ContactDr Virendra Singh

PGIMER CHANDIGARH

virendrasingh100@hotmail.com7087009338

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026