A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

Study Identifier:

242-12-233

ClinicalTrials.gov Identifier:

NCT01859923

EudraCT Identifier:

2012-004620-38

EU CT ID:

N/A

Study Contact Information:

N/A

Study Complete

Subscribe to Updates

Results Availables

Study Protocol

Available Language: English

Download document(s)

Statistical Analysis Plan

Available Language: English

Download document(s)

Study Details

Medical Condition

Tuberculosis

Study Drug

Drug: Delamanid
Drug: Delamanid Pediatric Formulation (DPF)
Drug: Optimized Background Regimen (OBR)

Date

Jul 2013 - Jan 2020

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 0 - 17 Years

Requirements Information

Inclusion and Exclusion Criteria

Inclusion Criteria

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 Criteria

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)

Protocol 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-tuberculosis drugs in pediatric participants who completed Study 242-12-232 (NCT01856634).

Study Locations

Location

Status

Location

De La Salle Health Sciences Institute

Dasmariñas, Cavite, Philippines

Status

N/A

Location

Lung Center of the Philippines

Quezon City, National Capital Region, Philippines

Status

N/A

Location

Brooklyn Chest Hospital

Ysterplaat, Cape Town, South Africa

Status

N/A

July 2025 01US25EUC0279

Requirements information

Inclusion criteria

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 criteria

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)

A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)

Results Availables

Study Details

Protocol Summary

Study Locations

© 2025 Otsuka America Pharmaceutical,

Inc All rights reserved.

July 2025 01US25EUC0279