ClinicalTrials.gov

History of Changes for Study: NCT01424670
Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis
Latest version (submitted May 13, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 26, 2011 None (earliest Version on record)
2 September 19, 2011 Recruitment Status, Study Status and Contacts/Locations
3 May 3, 2012 Contacts/Locations and Study Status
4 December 4, 2012 Contacts/Locations and Study Status
5 December 13, 2013 Recruitment Status, Contacts/Locations, Study Status and Study Design
6 December 18, 2014 Study Status and Contacts/Locations
7 March 4, 2015 Study Status
8 March 25, 2015 Arms and Interventions and Study Status
9 June 29, 2015 Outcome Measures, Study Status and Study Description
10 October 13, 2015 Study Status
11 January 9, 2017 Recruitment Status, Contacts/Locations, Outcome Measures and Study Status
12 January 30, 2017 Arms and Interventions and Study Status
Show
Results Submission Events
13 May 13, 2019 Study Status, Contacts/Locations, Arms and Interventions, Outcome Measures, More Information, Conditions, Study Description, Study Identification, Adverse Events, Baseline Characteristics, Participant Flow and Eligibility
Comparison Format:

Scroll up to access the controls

Study NCT01424670
Submitted Date:  August 26, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 242-09-213
Brief Title: Safety and Efficacy Trial of Delamanid for 6 Months in Patients With Multidrug Resistant Tuberculosis
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2011
Overall Status: Not yet recruiting
Study Start: September 2011
Primary Completion: August 2013 [Anticipated]
Study Completion: September 2015 [Anticipated]
First Submitted: August 25, 2011
First Submitted that
Met QC Criteria:
August 26, 2011
First Posted: August 29, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 26, 2011
Last Update Posted: August 29, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
Detailed Description: 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.
Open or close this module Conditions
Conditions: Multidrug Resistant Tuberculosis
Keywords: Multidrug resistant tuberculosis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 390 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo tablet Drug: Placebo
100mg BID for 2 months and 200mg QD for 4 months
Experimental: Delamanid Drug: Delamanid
100mg BID for 2 months and 200mg QD for 4 months
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Sputum Culture Conversion
[ Time Frame: 2 months ]

Proportion of patients achieving SCC at 2 months.
2. Time to Sputum Culture Conversion
[ Time Frame: 6 months ]

Distribution of the time to SCC during the 6-months of IMP treatment.
Secondary Outcome Measures:
1. Sputum Culture Conversion
[ Time Frame: 2 months ]

Proportion of patients with SCC using solid culture media
2. Sputum Culture Conversion
[ Time Frame: 6 months ]

Proportion of patients with SCC using the MGIT system
3. Durability of Sputum Culture Conversion
[ Time Frame: 18 months ]

Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
4. Time to Sputum Culture Conversion
[ Time Frame: 6 months ]

Distribution of the time to SCC using solid culture media during 6-months of IMP treatment.
5. Sputum Culture Conversion
[ Time Frame: 6 months ]

Proportion of patients with SCC using solid culture media
6. Durability of Sputum Culture Conversion
[ Time Frame: 30 months ]

Durability of SCC with the MGIT system during the Continuation Treatment and Post-treatment Follow-up periods
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 69 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 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
Open or close this module Contacts/Locations
Central Contact Person: Keinya Lee, MS
Telephone: 240.780.4291
Email: keinya.lee@otsuka-us.com
Study Officials: Carolyn Pettersen, MD
Study Director
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations: Estonia
Tartu University Hospital, Lung Clinic
Tartu, Estonia, 51014
Contact:Contact: Lia Loime 00372 59030980 lia.loime@covance.com
Contact:Principal Investigator: Manfred Danilovits
Latvia
State Agency "Infectology Center of Latvia" Clinic of Tuberculosis and Lung Diseases
Riga, Latvia, LV-2118
Contact:Contact: Rasa Kotello 00371 67914469 rasa.kotello@cratrial.com
Contact:Principal Investigator: Andra Cirule, Diploma of Physician
Lithuania
Public Institution Republican Siauliai Hospital Subsidiary Hospital of Tuberculosis and Lung Diseases
Siauliai, Lithuania, LT-76231
Contact:Contact: Virginija Gajauskiene 00370 41524336 virginija.gaj@gmail.com
Contact:Principal Investigator: Virgaine Bielskiene
Infectious Diseases and Tuberculosis Hospital affiliate of Public institution Vilnius University Hospital
Vilnius, Lithuania, LT-10214
Contact:Contact: Egle Garbuziene 00370 52101449 egle.garbuziene@dokumeds.com
Contact:Principal Investigator: Valerija Edita Davidaviciene
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services