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Trial record 3 of 22 for:    delamanid

A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683

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ClinicalTrials.gov Identifier: NCT02573350
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
A phase 2, multicenter, uncontrolled, open-label trial in patients with MDR-TB. Only patients who completed Trial 204 were eligible. The trial was performed globally at 14 sites qualified to treat MDR-TB. All 434 patients who completed Trial 204 were eligible for this trial if there was still potential clinical benefit to them and all inclusion criteria and no exclusion criteria were met.

Condition or disease Intervention/treatment Phase
Tuberculosis, Multidrug-Resistant Drug: Delamanid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID With Optional Titration to 200 mg BID for up to Six Months Exposure in Patients With Pulmonary Multi-drug Resistant Tuberculosis
Study Start Date : March 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: Delamanid
All patients received an initial dose of 100 mg BID (200 mg total daily dose), with an option to titrate to 200 mg BID (400 mg total daily dose) after an initial 2-week hospitalization at the investigator's discretion.
Drug: Delamanid
Delamanid was administered orally as 50-mg tablets.
Other Names:
  • OPC-67683
  • Deltyba




Primary Outcome Measures :
  1. Subjects with changes in vital signs reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Day 1, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 ]
  2. Subjects with changes in ECG reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Day 1, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 ]
  3. Subjects with changes in audiometry reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Day 1, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 ]
  4. Subjects with changes in Hematology, chemistry, and urinalysis assessments reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Weeks 4, 10, 14, 18, 22, 26 ]
  5. Adverse Events [ Time Frame: Baseline, Day 1, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 and Follow-up ]
  6. Subjects with changes in Visual acuity reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 ]
  7. Subjects with changes in Neurological and psychiatric assessments reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Weeks 1, 2, 4, 6, 10, 14, 18, 22, 26 ]
  8. Subjects with changes in Coagulation (PT and aPTT) reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Weeks 4, 10, 14, 18, 22, 26 ]
  9. Subjects with changes in cortisol reported as Treatment Emergent Adverse Events [ Time Frame: Baseline, Weeks 4, 10, 14, 18, 22, 26 ]

Secondary Outcome Measures :
  1. Proportion of Treatment Responders using the MGIT culture system. [ Time Frame: 6 months ]
  2. Proportion of Treatment Responders using solid culture medium. [ Time Frame: 6 months ]
  3. Proportion of Treatment Non-responders using the MGIT culture system. [ Time Frame: 6 months ]
  4. Proportion of Treatment Non-responders using solid culture medium. [ Time Frame: 6 months ]
  5. Proportion of Sustained Converters using the MGIT culture system. [ Time Frame: 6 months ]
  6. Proportion of Sustained Converters using solid culture medium. [ Time Frame: 6 months ]
  7. Proportion of New Converters using the MGIT culture system. [ Time Frame: 6 months ]
  8. Proportion of New Converters using solid culture medium. [ Time Frame: 6 months ]
  9. Proportion of Non-converters using the MGIT culture system. [ Time Frame: 6 months ]
  10. Proportion. of Non-converters using solid culture medium. [ Time Frame: 6 months ]
  11. Proportion of Reverters using the MGIT culture system. [ Time Frame: 6 months ]
  12. Proportion of Reverters using solid culture medium. [ Time Frame: 6 months ]
  13. Proportion. of patients who develop resistance to delamanid while on treatment at any visit. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written, informed consent prior to all trial-related procedures
  • Male or female patients aged between 18 and 64 years, inclusive, at the time of enrollment into the 242-07-204 trial. Patients who were 64 years at the time of 204 enrollment and who are now 65 years, are eligible for this trial.
  • Patients who have completed trial 242-07-204
  • Patients judged by the investigator to have the potential for clinical benefit from OPC-67683 exposure
  • Able to produce sputum for mycobacterial culture or able to obtain sputum produced through induction
  • Female patients of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control throughout the participation in the trial and for 22 weeks after last dose.
  • Male patients must agree to use an adequate method of contraception (double barrier) throughout the participation in the trial and for 30weeks after last dose.

Exclusion Criteria:

  • Greater than 30 days has elapsed from the patient's date of completion in the 242-07-204 trial or greater than 30 days has elapsed since the patient's trial investigator's site was initiated in this trial, whichever is later.a
  • A history of allergy to any nitro-imidazoles or nitro-imidazole derivates at any time.
  • Use of the medications in Section 5.4.7 including: use of amiodarone at any time during the previous 12 months, use of other anti-arrhythmics for the previous 30 days, and use of certain other medications, including certain anti-depressants, anti-histamines, and macrolides, for the previous 14 days.
  • Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels ≥265 mol/L or hepatic impairment characterized by ALT and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory reference range from the screening lab results.
  • Current clinically relevant changes in the ECG (between Trial 204 day 56 assessment and baseline) such as any atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in both male and female patients), or the QTcF interval over 450 msec in male patients and 470 msec in female patients.
  • Current clinically relevant cardiovascular disorder such as heart failure, coronary artery disease, uncontrolled or poorly controlled hypertension, arrhythmia, tachyarrhythmia or status after myocardial infarction.
  • Any patients with known or reported significant psychiatric history.
  • For patients with HIV infection, CD4 cell count less than 350/mm3 or on treatment with antiretroviral medication for HIV infection.
  • Karnofsky score under 50% while hospitalized and less than 60% while not hospitalized.
  • Any current diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated.
  • Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
  • Known or suspected alcohol abuse, that is, abuse sufficient enough to compromise the safety or cooperation of the patient in the opinion of the investigator.
  • Administered an IMP within 1 month prior to Visit 1 other than OPC-67683 given as IMP in trial 242-07-204.
  • Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the informed consent form.
  • Recent use of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, tetrahydrocannabinol, barbiturates, and opiates as determined by a urine drug screen, unless evidence is provided that the positive drug screen is the result of authorized medications or products prescribed by a physician for a non-abuse related indication.
  • Any disorder that in the judgment of the investigator makes the patient not a good candidate for the trial or may prevent the patient from reliably participating in the entire course of the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573350


Locations
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China
Beijing Chest Hospital
Beijing, China, 101149
Estonia
North Estonian Medical Centre Foundation Center of Pulmonology
Tallinn, Estonia, 13419
Tartu University Lung Hospital
Tartu, Estonia, 51014
Korea, Republic of
Younsei University Medical Center
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Latvia
State Agency of Tuberculosis and Lung Disease
Riga, Latvia, LV2118
Peru
Hospital Nacional Sergio E. Bernales
Lima, Peru, 41
Philippines
Tropical Disease Foundation
Makati City, Philippines, 1229
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02573350     History of Changes
Other Study ID Numbers: 242-07-208
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections