Home » Trials » SLCTR/2018/015


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

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SLCTR Registration Number

SLCTR/2018/015


Date of Registration

21 May 2018

The date of last modification

Mar 03, 2019



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 or 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/practice


Assignment

Parallel


Purpose

Supportive care


Study Phase

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)

[

At baseline and 90 days

]
2.

Change in CTP (Child-Turcotte-Pugh) score

[

At baseline and 90 days

]
3.

Survival

[

At 90 days

]

Secondary outcome(s)

1.

None

[

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


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2017-11-04


Approval number

BSMMU/2017/12508


Details of Ethics Review Committee

Name: Institutional Review Board, Bangabandhu Sheikh Mujib Medical University
Institutional Address:Shahbag, Dhaka, Bangladesh
Telephone:+880-8612550
Email: registrar@bsmmu.edu.bd

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





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results