Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

• Status: Completed
• Trial end date: 2016-07-04
• Target enrollment: 0
• Participant gender: All

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 treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).