NCT02686385

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
Last Updated

December 18, 2017

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

February 8, 2016

Last Update Submit

December 15, 2017

Conditions

Drug Induced Liver Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Improvement in of Histology.

    20 days

  • Improvement in CBC profile

    20 days

  • Improvement in coagulation profile

    20 days

  • Improvement in KFT profile

    20 days

  • Proportion of patients develop adverse effects in both groups.

    20 days

Study Arms (2)

Prednisolone + N-Acetylcysteine

EXPERIMENTAL

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

Drug: PrednisoloneDrug: N-Acetylcysteine

N-Acetylcysteine

ACTIVE COMPARATOR

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

Drug: N-Acetylcysteine

Interventions

PrednisoloneDRUG
Prednisolone + N-Acetylcysteine
N-AcetylcysteineDRUG

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-AcetylcysteinePrednisolone + N-Acetylcysteine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with severe DILI (Drug Induced Liver Injury)
  • Age more than or equal to 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

PrednisoloneAcetylcysteine

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Dr Anand Kulkarni V, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 19, 2016

Study Start

March 1, 2016

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

December 18, 2017

Record last verified: 2016-08

Locations

IN(1)