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

I

Institute of Liver and Biliary Sciences, India

Status

Terminated

Conditions

Drug Induced Liver Injury

Treatments

Drug: N-Acetylcysteine
Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT02686385
ILBS-DILI-001

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Prednisolone + N-Acetylcysteine
Experimental group
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
Treatment:
Drug: N-Acetylcysteine
Drug: Prednisolone
N-Acetylcysteine
Active Comparator group
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
Treatment:
Drug: N-Acetylcysteine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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