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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02788240
Other study ID # ILBS-ACLF-008
Secondary ID
Status Terminated
Phase N/A
First received March 22, 2016
Last updated February 5, 2018
Start date May 1, 2016
Est. completion date July 15, 2017

Study information

Verified date February 2018
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date July 15, 2017
Est. primary completion date July 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
Peg GCSF

Biological:
20% Albumin

Dietary Supplement:
Nutrition

Other:
Bowel wash

Drug:
Terlipressin 1- 4mg,if indicated

Meropenem or Imepenem, if indicated

Placebo


Locations

Country Name City State
India Institute of liver and Biliary Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transplant free survival in both groups 1 year
Secondary Quantitative assessment of CD34 positive cells in serum in both groups. On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done 1 year
Secondary Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups. On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done 1 year
Secondary Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups. 1 year
Secondary Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups. 1 year
Secondary Development of new onset complications such as hepatic encephalopathy in both groups. 1 year
Secondary Development of new onset complications such as hepatorenal syndrome in both groups. 1 year
Secondary Development of new onset complications such as sepsis in both groups. 1 year
Secondary Development of new onset complications such as Hepatocellular carcinoma (HCC). 1 year
Secondary Total number of CD34 positive cells in histopathological examination of bone marrow in both groups 1 year
Secondary No of adverse events in both groups 1 year
Secondary Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups 1 year
Secondary Reduction in HBV DNA level in both groups. 1 year
Secondary Number of patients who will restart alcohol abuse during the follow up period in both groups. 1 year
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