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

Drug Induced Liver Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02686385
• Other study ID #: ILBS-DILI-001
• Status: Terminated
• Phase: N/A
• First received: February 8, 2016
• Last updated: December 15, 2017
• Start date: March 1, 2016
• Est. completion date: August 31, 2016

Study information

• Verified date: August 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug Induced Liver Injury
• Wounds and Injuries

Intervention

Drug:
• Prednisolone

• 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

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with normalization of LFT (Liver Function Test) in both groups.	Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.	20 days
Secondary	Improvement in of Histology.	Improvement is defined as decrease in inflammation, decrease in cholestasis.	20 days
Secondary	Improvement in CBC profile	Improvement is defined normalization of CBC profile.	20 days
Secondary	Improvement in coagulation profile	Improvement is defined normalization of Coagulation profile.	20 days
Secondary	Improvement in KFT profile	Improvement is defined normalization of KFT profile.	20 days
Secondary	Proportion of patients develop adverse effects in both groups.		20 days