Status:
COMPLETED
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Multidrug-resistant Tuberculosis
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of t...
Detailed Description
The primary objective of this trial is to evaluate the efficacy of delamanid administered orally as 100 milligrams (mg) twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months i...
Eligibility Criteria
Inclusion
- Provide written, informed consent
- Current diagnosis of MDR TB
- Chest radiograph consistent with TB
- Able to produce sputum
- Negative urine pregnancy test and agree to use a highly effective method of birth control and/or adequate method of contraception
Exclusion
- Allergy to any nitro-imidazoles or nitro-imidazole derivates
- Diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated
- Use of disallowed medications
- Renal impairment
- Abnormal electrocardiogram (ECG) results
- Cardiovascular disorders
- Body mass index (BMI) \< 16 kg/m\^2
- Karnofsky score \< 50%
- Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy
- Alcohol abuse
- Pregnant, breast-feeding, or planning to conceive or father a child
- Recent use of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, tetrahydrocannabinol, barbiturates, and opiates
- Previous exposure to delamanid
- Administered an investigational medicinal product (IMP) within 1 month prior to Screening (Days -21 to -2).
- Evidence of extensively drug-resistant TB based on the definition from WHO
- Human immunodeficiency virus (HIV) co-infection for participants screened at sites not participating in the HIV subtrial (data from the HIV subtrial will be reported separately from the Clinical Study Report for Study 242-09-213).
Key Trial Info
Start Date :
September 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2016
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT01424670
Start Date
September 2 2011
End Date
July 4 2016
Last Update
May 15 2019
Active Locations (17)
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1
Tartu, Estonia, 51014
2
Riga, Latvia, LV-2118
3
Šiauliai, Lithuania, LT-76231
4
Vilnius, Lithuania, LT-10214