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

Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02686385

Enrollment

Registered

2016-02-19

Start date

2016-03-01

Completion date

2016-08-31

Last updated

2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Induced Liver Injury

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.

Interventions

DRUGPrednisolone

DRUGN-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with normalization of LFT (Liver Function Test) in both groups.	20 days	Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.

Secondary

Measure	Time frame	Description
Improvement in of Histology.	20 days	Improvement is defined as decrease in inflammation, decrease in cholestasis.
Improvement in CBC profile	20 days	Improvement is defined normalization of CBC profile.
Improvement in coagulation profile	20 days	Improvement is defined normalization of Coagulation profile.
Improvement in KFT profile	20 days	Improvement is defined normalization of KFT profile.
Proportion of patients develop adverse effects in both groups.	20 days	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026