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

Sponsor ID
242-12-233
Clinicaltrials.gov ID
NCT01859923
EudraCT ID
2012-004620-38
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
242-12-233
Trial Details
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Age
0 - 17 Years
Therapeutic Area
  • Tuberculosis
    • Sex
    Female & Male
    Trial Dates
    Jul 2013 - Jan 2020
    Healthy Volunteers
    No
    • 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
    • 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)

    Study 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).

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Delamanid
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    37
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Successfully completed Trial 242-12-232
    • * Confirmed diagnosis of MDR-TB OR

    Exclusion Criteria

    • * Participants who have not completed Trial 242-12-232
    • * Laboratory evidence of active hepatitis B or C
    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)

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    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

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