At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 175 enrolled

Drug / intervention

Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day)drug

Likely dose

Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day)from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00405301

NCT00405301Phase 4Completed

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Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Antituberculosis Treatment Induced Hepatotoxicity

All India Institute of Medical Sciences·interventional·Posted Nov 30, 2006·Updated Feb 16, 2012

In Brief

A Phase 4 clinical trial evaluating Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day) for Drug Induced Hepatotoxicity and Tuberculosis. Completed, enrolled 175 participants across 2 sites.

Detailed Summary

Purpose of the study is to evaluate the safety and efficacy of different re-introduction regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such patients who developed drug induced liver damage.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDrug Induced Hepatotoxicity, Tuberculosis

CountriesIndia

Collaborators--

Timeline

Phase 4CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedNov 2006

Enrollment StartDec 2006

Primary CompletionJun 2008

Study CompletionDec 2008

TodayJul 2026

First PostedNov 30, 2006

Enrollment StartDec 1, 2006

Primary CompletionJun 1, 2008

Study CompletionDec 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 19.6 years ago

Interventions

Rifampicin(max dose 10 mg/kg/day), Isoniazide (max dose 5 mg/kg/day) and Pyrazinamide (max dose 25 mg/kg/day)drug

Patients who develop ATT drug induced hepatotoxicity will be divided into 3 arms .Arm 1,2,3 will be given drugs as described in detailed description of the title.