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

• Status: Terminated
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Acetylcysteine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; N-monoacetylcystine; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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