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

Not Applicable

Terminated

• Conditions: Drug Induced Liver Injury
• Interventions: Drug: Prednisolone; Drug: N-Acetylcysteine

• Registration Number: NCT02686385
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-19
• Study Start: 2016-03-01
• Status Verified: 2016-08
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone + N-Acetylcysteine	Prednisolone	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
N-Acetylcysteine	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
Prednisolone + N-Acetylcysteine	N-Acetylcysteine	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of patients develop adverse effects in both groups.	20 days
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.

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India