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

NCT ID: NCT04066179

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-07

Study Completion Date

2021-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisolone+G-CSF

Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days

Group Type EXPERIMENTAL

Gcsf

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

Prednisolone 40 mg for initial 7 days

Prednisolone

Prednisolone 40 mg/day for 7 days

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Prednisolone 40 mg for initial 7 days

Granulocytes-Colony Stimulating Factor

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

Group Type EXPERIMENTAL

Gcsf

Intervention Type DRUG

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

Interventions

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Gcsf

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

Intervention Type DRUG

Prednisolone

Prednisolone 40 mg for initial 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria

* Presence of active infections
* Acute Gastrointestinal bleed
* Hepatorenal syndrome
* Patient unwilling
* Discriminant Function \>90
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases
* Pregnancy
* Hemophagocytic lymphohistiocytosis (HLH)
* Hb\<8 and baseline White Blood Cell\>25000
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr Ajay Mishra, MD

Role: CONTACT

01146300000

Facility Contacts

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Dr Ajay Mishra, MD

Role: primary

01146300000

Other Identifiers

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ILBS-AH-03

Identifier Type: -

Identifier Source: org_study_id

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