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Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

Primary Purpose

Drug Induced Liver Injury

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Prednisolone
N-Acetylcysteine
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Induced Liver Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with severe DILI (Drug Induced Liver Injury)
  • Age more than or equal to 18 years

Exclusion Criteria:

  • Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive
  • Patients with sepsis
  • AMA positive
  • Low Ceruloplasmin
  • Transferrin saturation >45%
  • Patients with Cirrhosis
  • Patients with h/o jaundice prior to the intake of drug

Sites / Locations

  • Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prednisolone + N-Acetylcysteine

N-Acetylcysteine

Arm Description

Prednisolone for 20 days with NAC (N-Acetylcysteine) NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h

NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h

Outcomes

Primary Outcome Measures

Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.

Secondary Outcome Measures

Improvement in of Histology.
Improvement is defined as decrease in inflammation, decrease in cholestasis.
Improvement in CBC profile
Improvement is defined normalization of CBC profile.
Improvement in coagulation profile
Improvement is defined normalization of Coagulation profile.
Improvement in KFT profile
Improvement is defined normalization of KFT profile.
Proportion of patients develop adverse effects in both groups.

Full Information

First Posted
February 8, 2016
Last Updated
December 15, 2017
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02686385
Brief Title
Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury
Official Title
Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Steroids were given for 2 patients who had biopsy proven Drug induced Liver Injury and both have them developed sepsis.
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

5. Study Description

Brief Summary
Intervention - Subjects will be randomized to 2 groups Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine) Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals. Stopping rule-Development of sepsis, worsening of Liver functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Induced Liver Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone + N-Acetylcysteine
Arm Type
Experimental
Arm Description
Prednisolone for 20 days with NAC (N-Acetylcysteine) NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
Arm Title
N-Acetylcysteine
Arm Type
Active Comparator
Arm Description
NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Description
NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
Primary Outcome Measure Information:
Title
Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
Description
Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Improvement in of Histology.
Description
Improvement is defined as decrease in inflammation, decrease in cholestasis.
Time Frame
20 days
Title
Improvement in CBC profile
Description
Improvement is defined normalization of CBC profile.
Time Frame
20 days
Title
Improvement in coagulation profile
Description
Improvement is defined normalization of Coagulation profile.
Time Frame
20 days
Title
Improvement in KFT profile
Description
Improvement is defined normalization of KFT profile.
Time Frame
20 days
Title
Proportion of patients develop adverse effects in both groups.
Time Frame
20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with severe DILI (Drug Induced Liver Injury) Age more than or equal to 18 years Exclusion Criteria: Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive Patients with sepsis AMA positive Low Ceruloplasmin Transferrin saturation >45% Patients with Cirrhosis Patients with h/o jaundice prior to the intake of drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Anand Kulkarni V, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

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Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

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