Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01424670
First received: August 25, 2011
Last updated: December 13, 2013
Last verified: December 2013

August 25, 2011
December 13, 2013
September 2011
May 2014   (final data collection date for primary outcome measure)
  • Sputum Culture Conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Proportion of patients achieving SCC at 2 months.
  • Time to Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Distribution of the time to SCC during the 6-months of IMP treatment.
Same as current
Complete list of historical versions of study NCT01424670 on ClinicalTrials.gov Archive Site
  • Sputum Culture Conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Proportion of patients with SCC using solid culture media
  • Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of patients with SCC using the MGIT system
  • Durability of Sputum Culture Conversion [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
  • Time to Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Distribution of the time to SCC using solid culture media during 6-months of IMP treatment.
  • Sputum Culture Conversion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of patients with SCC using solid culture media
  • Durability of Sputum Culture Conversion [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis
A Phase 3, Multicenter,Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis

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.

The purpose of this trial is to evaluate the efficacy of delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background regimen (OBR) versus placebo with OBR during the 6-month intensive phase of MDR TB treatment. This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted globally in 2 parallel groups at approximately 15 sites qualified to treat MDR TB. In addition, a subtrial comprised of human immunodeficiency virus (HIV) positive patients who will be on antiretrovirals (ARVs) during the trial and will be randomized to OBR plus placebo or OBR plus delamanid will be conducted at a limited number of these sites that have been prequalified as having an integrated approach to TB and HIV treatment and management and a sufficient population of MDR TB patients co-infected with HIV for enrollment.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Multidrug Resistant Tuberculosis
  • Drug: Delamanid
    100mg BID for 2 months and 200mg QD for 4 months
  • Drug: Placebo
    100mg BID for 2 months and 200mg QD for 4 months
  • Placebo Comparator: Placebo tablet
    Intervention: Drug: Placebo
  • Experimental: Delamanid
    Intervention: Drug: Delamanid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
511
May 2016
May 2014   (final data collection date for primary outcome measure)

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 ECG
  • Cardiovascular disorders
  • BMI < 16 kg/m2
  • 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/metamphetamine, tetrahydrocannabinol, barbiturates, and opiates
  • Previous exposure to delamanid
  • Administered an IMP within 1 month prior to Visit 1
  • Evidence of XDR TB based on the definition from WHO
  • HIV co-infection for patients screened at sites not participating in the HIV subtrial
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Peru,   South Africa,   Philippines,   Lithuania,   Moldova, Republic of,   Latvia,   Estonia
 
NCT01424670
242-09-213
Yes
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Not Provided
Study Director: Carolyn Petersen, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP