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

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)

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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