Anti-tuberculosis (TB) Drug Levels and Hepatotoxicity
Measurement of Drug Levels and Their Correlation With Hepatotoxicity During Antituberculosis Treatment
2 other identifiers
observational
72
1 country
2
Brief Summary
The purpose of this study is to evaluate plasma levels of hepatotoxic anti-tuberculous drugs (isoniazid, rifampicin, pyrazinamide plus significant metabolites) among patients on antituberculosis treatment (ATT) and compare the same among those who develop drug induced hepatitis on follow up versus those who do not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedNovember 10, 2009
November 1, 2009
1.4 years
June 29, 2009
November 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of plasma levels of isoniazid, rifampicin, pyrazinamide among cases and controls
20 months
Secondary Outcomes (1)
Evaluation of plasma levels of any significant metabolites among cases and controls
20 months
Study Arms (1)
2
Cases - those patients who develop DIH while on regular treatment with anti-TB drugs. Controls - patients who do not develop DIH while on regular treatment with anti-TB drugs.
Eligibility Criteria
Subjects: Patients with diagnosis of CatI/CatIII Tuberculosis attending the out-patient department of the All India Institute of Medical Sciences, New Delhi, will form the study population. Cases - those patients who develop DIH while on regular treatment with anti-TB drugs Controls - age, sex matched patients who do not develop DIH while on regular treatment with anti-TB drugs
You may qualify if:
- Patients diagnosed to be suffering from CatI/CatIII tuberculosis by a physician
- Age: 16-65 years
- Patient having normal baseline Liver function (AST/ALT1 \< 50/50, serum bilirubin \< 1.5 mg/dl)
You may not qualify if:
- Patients receiving any other drug known to be metabolized by liver by cytochrome P450 3A4 or P-glycoprotein
- Patients diagnosed to have acute viral hepatitis A, B, C, or E or carrier for HBV \& HCV
- Known HIV positive patients
- Presence of chronic liver disease or renal insufficiency
- Concomitant administration of other potential hepatotoxic drugs (methotrexate, phenytoin, valproate)
- Chronic alcoholics who consume \> 48 g of alcohol/day for at least one year
- Pregnant women
- Subjects not willing to participate
- Known patients with malabsorption or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
All India Institute of Medical Sciences
New Delhi, New Delhi, 110029, India
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Surendra K Sharma, MD,Ph.D
All India Institute of Medical Sciences, New Delhi-110029, India
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
November 1, 2007
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
November 10, 2009
Record last verified: 2009-11