Status:
COMPLETED
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Multidrug Resistant Tuberculosis
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti...
Detailed Description
This study will assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid plus an optimized background regimen in pediatric participants with MDR-TB over a 6-month treatment period....
Eligibility Criteria
Inclusion
- Successfully completed Trial 242-12-232
- Confirmed diagnosis of MDR-TB OR
- Presumptive diagnosis of pulmonary or extrapulmonary MDR-TB including one of the following:
- Clinical specimen suggestive of tuberculosis disease
- Persistent cough lasting \> 2 weeks
- Fever, weight loss, and failure to thrive
- Findings on recent chest radiograph (prior to Visit 1) consistent with TB AND
- Household contact with a person with known MDR-TB or with a person who died while appropriately taking drugs for sensitive TB OR
- On first-line TB treatment but with no clinical improvement
- Negative urine pregnancy test for female participants who have reached menarche
- Written informed consent/assent
Exclusion
- Participants who have not completed Trial 242-12-232
- Laboratory evidence of active hepatitis B or C
- Children with body weight \< 5.5 kg
- For participants with human-immunodeficiency virus (HIV) co-infection, cluster difference-4 (CD4) cell count ≤ 1000/mm\^3 for children 1-5 years old, and ≤ 1500/mm\^3 for children less than 1 year old
- History of allergy to metronidazole and any disease or condition in which metronidazole is required
- Use of amiodarone within 12 months or use of other predefined antiarrhythmic medications within 30 days prior to first dose of delamanid
- Serious concomitant conditions
- Pre-existing cardiac conditions
- Abnormalities in Screening electrocardiogram (ECG) \[including atrio-ventricular (AV) block, blood brain barrier (BBB) or hemi-block, QRS prolongation \> 120 milliseconds (ms), or QT interval corrected by Fridericia's formula (QTcF) \> 450 ms in both males and females\]
- Concomitant condition such as renal impairment characterized by serum creatinine levels \> 1.5 mg/dL, hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3x upper limit of normal (ULN)), or hyperbilirubinemia characterized by total bilirubin \> 2x ULN
- Current diagnosis of severe malnutrition or kwashiorkor
- Positive urine drug screen (Groups 1 and 2 only)
- Rifampicin and/or moxifloxacin within 1 week prior to the first dose of delamanid and/or any prior or concurrent use of bedaquiline
- Lansky Play Performance Score \< 50 (not applicable for children \< 1 year old) or Karnofsky Score \< 50
- Administered an investigational medicinal product (IMP) within 1 month prior to Visit 1 other than delamanid given as IMP in Trial 242-12-232
- Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the informed consent form (Groups 1 and 2 only)
Key Trial Info
Start Date :
July 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01859923
Start Date
July 20 2013
End Date
January 13 2020
Last Update
November 23 2020
Active Locations (3)
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1
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines
2
Lung Center of the Philippines
Quezon City, National Capital Region, Philippines
3
Brooklyn Chest Hospital
Ysterplaat, Cape Town, South Africa