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To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase

NCT ID: NCT02788240

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-07-15

Brief Summary

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All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).

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Detailed Description

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Conditions

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Acute on Chronic Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Peg GCSF with standard medical therapy

Group Type EXPERIMENTAL

Peg GCSF

Intervention Type DRUG

20% Albumin

Intervention Type BIOLOGICAL

Nutrition

Intervention Type DIETARY_SUPPLEMENT

Bowel wash

Intervention Type OTHER

Terlipressin 1- 4mg,if indicated

Intervention Type DRUG

Meropenem or Imepenem, if indicated

Intervention Type DRUG

Placebo with standard medical therapy

Group Type ACTIVE_COMPARATOR

20% Albumin

Intervention Type BIOLOGICAL

Nutrition

Intervention Type DIETARY_SUPPLEMENT

Bowel wash

Intervention Type OTHER

Terlipressin 1- 4mg,if indicated

Intervention Type DRUG

Meropenem or Imepenem, if indicated

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Peg GCSF

Intervention Type DRUG

20% Albumin

Intervention Type BIOLOGICAL

Nutrition

Intervention Type DIETARY_SUPPLEMENT

Bowel wash

Intervention Type OTHER

Terlipressin 1- 4mg,if indicated

Intervention Type DRUG

Meropenem or Imepenem, if indicated

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 18-65 years
* All patients who were known to have ACLF and have survived 3 months of the onset of acute event
* Patients willing to participate in the study

Exclusion Criteria

* Presence of AKI (Acute Kidney Injury)
* Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection)
* Sickle cell anemia
* HepatoCellular Carcinoma
* Hematological malignancies
* Multi organ failure
* Grade 3/ 4 HE (Hepatic Encephalopathy)
* HIV seropositivity
* Pregnancy
* Patients being taken up for transplant
* Refusal to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-ACLF-008

Identifier Type: -

Identifier Source: org_study_id

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