NCT02686385

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Induced Liver Injury

Interventions

Type	Name	Description
DRUG	Prednisolone
DRUG	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

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-08-31
• Completion: 2016-08-31
• First posted: 2016-02-19
• Last updated: 2017-12-18

Locations

1 site across 1 country: India