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A Trial Of Intravenous N-Acetylcysteine In The Management Of Antituberculous Drug-Induced Hepatitis

NCT02182167 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-02-19

No results posted yet for this study

Summary

We will conduct a randomized placebo controlled trial to determine whether administration of intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in paracetamol poisoning, can improve recovery from hepatotoxicity.

Conditions

  • Drug-Induced Liver Injury

Interventions

DRUG

IV N-acetylcysteine (NAC)

DRUG

Water

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Karen Cohen · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02182167 on ClinicalTrials.gov