Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury
NCT ID: NCT02686385
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
4 participants
INTERVENTIONAL
2016-03-01
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prednisolone + 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
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age more than or equal to 18 years
Exclusion Criteria
* Patients with sepsis
* AMA positive
* Low Ceruloplasmin
* Transferrin saturation \>45%
* Patients with Cirrhosis
* Patients with h/o jaundice prior to the intake of drug
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr Anand Kulkarni V, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ILBS-DILI-001
Identifier Type: -
Identifier Source: org_study_id