Home » Trials » SLCTR/2018/015


The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure -

SLCTR Registration Number

SLCTR/2018/015


Date of Registration

21 May 2018

The date of last modification

Jun 05, 2018



Application Summary


Scientific Title of Trial

The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure


Public Title of Trial

The Effect of granulocyte colony-stimulating factor and erythropoietin on survival in patients with Acute-on-Chronic Liver Failure.


Disease of Health Condition(s) Studied

Acute-on-Chronic Liver Failure.


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1212-4931


Any other number(s) assigned to the trial and issuing authority

BSMMU/2017/12508 (IRB: Bangabandhu Sheikh Mujib Medical University)


Trial Details


What is the research question being addressed?

Does the combination of granulocyte colony-stimulating factor and erythropoietin therapy improve survival of patients with Acute-on-Chronic Liver Failure?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Supportive care


Purpose

Phase 4


Intervention(s) planned

Study setting: The patient with Acute-on-Chronic Liver Failure will be admitted into the Department of Hepatology at Bangabandhu Sheikh Mujib Medical University, Dhaka. Patients will be allocated into 2 groups using simple randomization.

Group A will be receive standard medical treatment (supportive treatment like intravenous albumin, antibiotics, anti-virals and treatment of complications like variceal bleeding, hepato-renal syndrome,spontaneous bacterial peritonitis etc according to standard guidelines).

Group B will receive add on treatment with granulocyte colony-stimulating factor and erythropoietin. Granulocyte colony-stimulating factor will be administered at a dose of 5µg/Kg/day, subcutaneously, for six days along with subcutaneous Erythropoietin (40 mcg/wk) for a total of 4 weeks. Standard medical therapy will be provided as for Group A.


Inclusion criteria

• Age:>18 years
• Sex: both sexes
• Bilirubin > 5 mg/dl
• Coagulopathy (international normalized ratio > 1.5)
• Complicated by clinical ascites and/or encephalopathy within 4 weeks
• Patient with previously diagnosed or undiagnosed chronic liver disease
• Acute insult caused by reactivation of HBV, HBV Flare, HEV,HAV or any aetiology


Exclusion criteria

• Age <18 years
• Decompensated Cirrhosis
• Coexistent hepatocellular carcinoma (HCC)
• Patients on immune-modulator or cytotoxic/immunosuppressive therapy
• Co morbidity like heart failure, any malignancy and uncontrolled diabetic patients
. • Any previous known hypersensitivity to G-CSF and EPO
• Patients unwilling to take part in the study



Primary outcome(s)

  1. Change in MELD score (Model for end stage liver disease)

  2. Change in CTP (Child-Turcotte-Pugh) score

  3. Survival


Primary outcome(s) - Time of assessment(s)

  1. At baseline and 90 days
  2. At baseline and 90 days
  3. At 90 days

Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

36 (18 in each arm)


Countries of recruitment

Bangladesh


Anticipated start date

2018-06-01


Anticipated end date

2019-04-01


Recruitment status

Pending


State of ethics review approval

Institutional Review Board (I.R.B.) Clearance Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh on 4thNovember 2017. (Ref. No.: BSMMU/2017/12508)


Funding source

None (Investigator funded)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Md. Nazmul Haque
MD Student
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Mob: 01719976961

dr.nazmulhaquermc@gmail.com

Contact Person for Public Queries

Dr. Md. Ayub Al Mamun
Associate Professor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Mob: 01712091867

ayubmamunal@gmail.com


Primary study sponsor/organization

Dr. Md. Nazmul Haque
MD Student
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Mob: 01719976961

dr.nazmulhaquermc@gmail.com

Secondary study sponsor (If any)

None