Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

NCT01820208 | Completed DMC

• 1 other identifier: ILBS- AH-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Survival of subjects in both group

  4 weeks and 12 weeks

Secondary Outcomes (2)

• Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients

  4 weeks and 12 weeks

• Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients

  4 weeks and 12 weeks

Study Arms (2)

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)

Drug: G-CSF

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.

Drug: Placebo

Interventions

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.

Placebo

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)

G-CSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of active infections
• Acute GI bleed
• Hepatorenal syndrome
• Patient unwilling
• DF\>120
• Autoimmune hepatitis
• Hepatitis B, Hepatitis C, HIV cases
• Pregnancy

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 30664267 DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 28, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2016-08

Locations

IN (1)