Last reviewed · How we verify

NCT01820208

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

Completed NA Last updated 14 November 2017
What this trial tests

NA trial testing G-CSF in Severe Alcoholic Hepatitis in 28 participants. Completed in 1 June 2017.

Timeline
1 March 2014
Primary endpoint
1 June 2017
1 June 2017

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment28
Start date1 March 2014
Primary completion1 June 2017
Estimated completion1 June 2017
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 65, any sex, with Severe Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The knowns and unknowns of treatment for alcoholic hepatitis.
    Sehrawat TS, Liu M, Shah VH. · · 2020 · cited 76× · PMID 32277902 · DOI 10.1016/s2468-1253(19)30326-7
  2. Recent Insights Into the Role of Immune Cells in Alcoholic Liver Disease.
    Li S, Tan HY, Wang N, Feng Y, et al · · 2019 · cited 73× · PMID 31244862 · DOI 10.3389/fimmu.2019.01328
  3. Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial.
    Shasthry SM, Sharma MK, Shasthry V, Pande A, et al · · 2019 · cited 71× · PMID 30664267 · DOI 10.1002/hep.30516
  4. Targeting inflammation for the treatment of alcoholic liver disease.
    Xu MJ, Zhou Z, Parker R, Gao B. · · 2017 · cited 57× · PMID 28642119 · DOI 10.1016/j.pharmthera.2017.06.007
  5. Therapeutic opportunities for alcoholic steatohepatitis and nonalcoholic steatohepatitis: exploiting similarities and differences in pathogenesis.
    Greuter T, Malhi H, Gores GJ, Shah VH. · · 2017 · cited 46× · PMID 28878132 · DOI 10.1172/jci.insight.95354
  6. Alcohol-Related Liver Disease: An Overview on Pathophysiology, Diagnosis and Therapeutic Perspectives.
    Ha Y, Jeong I, Kim TH. · · 2022 · cited 19× · PMID 36289791 · DOI 10.3390/biomedicines10102530
  7. Pre-therapy liver transcriptome landscape in Indian and French patients with severe alcoholic hepatitis and steroid responsiveness.
    Sharma S, Maras JS, Das S, Hussain S, et al · · 2017 · cited 15× · PMID 28754919 · DOI 10.1038/s41598-017-07161-4
  8. New treatment options for alcoholic hepatitis.
    Shasthry SM, Sarin SK. · · 2016 · cited 15× · PMID 27099434 · DOI 10.3748/wjg.v22.i15.3892

Verify or expand the search:

Other trials of G-CSF

Trials testing the same drug.

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01820208.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing