To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03162419

Collaborator

(none)

Enrollment

Location

Arms

23.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study design-Open label randomized controlled trial

Study period-2 years

Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018

All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF

Condition or Disease	Intervention/Treatment	Phase
Acute-On-Chronic Liver Failure	Drug: Standard Medical Therapy Biological: Plasma Exchange Biological: GCSF	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF)-A Randomized Controlled Trial.

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Apr 25, 2019

Anticipated Study Completion Date :

Apr 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Medical Therapy The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.	Drug: Standard Medical Therapy The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
Experimental: Standard Medical Therapy + Plasma exchange + GCSF The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.	Drug: Standard Medical Therapy The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. Biological: Plasma Exchange High volume plasma exchange sessions till a maximum of ten sessions. Biological: GCSF The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28
Experimental: Standard Medical Therapy + GCSF The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28	Drug: Standard Medical Therapy The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. Biological: GCSF The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Arm

Intervention/Treatment

Active Comparator: Standard Medical Therapy

The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Drug: Standard Medical Therapy

Experimental: Standard Medical Therapy + Plasma exchange + GCSF

The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.

Drug: Standard Medical Therapy

Biological: Plasma Exchange

High volume plasma exchange sessions till a maximum of ten sessions.

Biological: GCSF

The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Experimental: Standard Medical Therapy + GCSF

The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Drug: Standard Medical Therapy

Biological: GCSF

The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Outcome Measures

Primary Outcome Measures

Transplant free survival [28 days]

Secondary Outcome Measures

Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups [Day 14]
Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups [Day 28]
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups [Day 14]
Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups [Day 28]
Improvement in APACHEII (by 2 points ) [2 years]
Improvement in MELD (by 2 points ) [2 years]
Improvement in SIRS by 2 points [2 years]
Improvement in SOFA (by 2 points ) [2 years]
Incidence of new onset sepsis and SIRS in both groups. [Day 28]
Side effects of therapy in both groups [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All consecutive patients in age group of 18-70 years with acute on chronic liver failure as defined by APASL criteria shall be included in the study.Only those patients who wish to be enrolled in the trial shall be included in the study.

Exclusion Criteria:

Steroid eligible patients with severe alcoholic hepatitis
Cirrhosis of liver with previous history of decompensation
Patients with severe cardiopulmonary disease
Pregnancy
Human Immmunodeficiency Virus infection
Hepatocellular carcinoma or extrahepatic malignancy
Chronic renal insufficiency on treatment with haemodialysis
Uncontrolled bleed or patients in disseminated intravascular coagulopathy
Patient with expected survival of less than 48 hours
Patients with moderate-severe acute respiratory distress syndrome
Hemodynamic instability with noradrenaline requirement of more than >0.5ug/kg/min or requirement of dual vasopressors
Patients with leukemoid reaction or total leucocyte count > 40,000/mm3
Patients diagnosed with Hemophagocytic Lymphohistiocytosis
Patients with known hypersensitivity to Granulocyte colony stimulating factor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT03162419

Other Study ID Numbers:

ILBS-ACLF-01

First Posted:

May 22, 2017

Last Update Posted:

Dec 3, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Failure

Hepatic Insufficiency

End Stage Liver Disease

Acute-On-Chronic Liver Failure

Study Results

No Results Posted as of Dec 3, 2018