NCT03703674

GCSF in Alcoholic Hepatitis

Granulocyte Colony Stimulating Factor in Alcoholic Hepatitis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Alcoholic hepatitis is related to very high mortality rate. About 40% of the patients are died within first 6 months after the detection of the clinical syndrome. Therefore, it is very essential for proper diagnosis and early treatment. In response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells. Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells. However, this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions. The studies has suggested Granulocyte-colony stimulating factors (G-CSF) can regenerate hepatocyte by fusing with hematopoietic cells, thereby enhancing the liver histology and survival rate. G-CSF is a cytokine capable to regulate a number of functions in neutrophils. In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis. In two of this studies there was a survival benefit with the use of G-CSF. Therefore we plan to study the safety and efficacy of G-CSF in the patients with alcoholic hepatitis.

Detailed description

Detailed Description: Patients with severe alcoholic hepatitis, admitted to Department of Hepatology PGIMER, Chandigarh will be included in the study. METHODS This will be an open label trial. A randomization code is generated by random number table. The patients will be randomized to receive standard medical therapy (SMT) only as control and therapy of G-CSF as case. There will be one control and one case as below: 1\) SMT (control) 2) G-CSF (case): G-CSF 5 mcg/kg every 12 hourly for consecutive 5 days This will be a single time therapy. Patients will be admitted in the department of hepatology and will be assessed everyday clinically as well as by laboratory tests during therapy to assess safety and effects of treatment. 1. Total leukocytes count will be assessed daily. 2. Circulating CD 34 positive cells will be measured on day 0 and 6 of G-CSF therapy. 3. In addition, ultrasonography will be performed at day 1 and 6 in order to evaluate difference in spleen size and portal vein flow. 4. Biochemical, coagulation, and hematological parameters (Liver function tests, Renal Function Tests, Prothrombin Time, International Normalised Ratio, etc.) will be monitored periodically, daily for 1 week, then weekly for 1month and monthly for three month. All patients will be followed at weekly interval for 1 month and then monthly for 3 months. Outcome: Primary Objectives: Survival at 3 months Secondary Objectives: Mobilisation of CD34 positive cells in peripheral blood.Clinical/biochemical improvement in liver function profile.Improvement in prognostic scores-Maddrey's Discriminant function, MELD score, and Child score. Safety and efficacy of G-CSF in alcoholic hepatitis

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	GCSF	Granulocyte-colony stimulating factors (G-CSF)

Timeline

• Start date: 2017-11-19
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2018-10-12
• Last updated: 2018-10-12

Locations

1 site across 1 country: India