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Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

NCT04066179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-09-09

No results posted yet for this study

Summary

The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Gcsf

Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days

DRUG

Prednisolone

Prednisolone 40 mg for initial 7 days

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-07
Primary Completion
2021-02-27
Completion
2021-02-27

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066179 on ClinicalTrials.gov