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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004620-38 | EudraCT Number |
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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).
This study will assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid plus an optimized background regimen in pediatric participants with MDR-TB over a 6-month treatment period. This long-term study, an extension of Study 242-12-232, will be conducted in participants who have completed Study 242-12-232.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 12 to 17 Years of Age | Experimental | Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) plus optimized background regimen (OBR) up to Day 182. Participants continued to receive OBR up to Day 365. |
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| Group 2: 6 to 11 Years of Age | Experimental | Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
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| Group 3: 3 to 5 Years of Age | Experimental | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
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| Group 4: Birth to 2 Years of Age | Experimental | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delamanid | Drug | Participants received adult formulation delamanid as per regimen specified in the arm description. Morning dose of the delamanid BID regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard dinner meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant and that does not necessarily have a causal relationship with the treatment. A TEAE is defined as an AE that occurred after the administration of investigational medicinal product (IMP). | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Abnormal Physical Examination Values | Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax; urogenital; audiometry assessment and visual assessment. Participants with abnormal values, as assessed by the investigator were reported. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Clinically Significant Abnormal Vital Sign Values | Vital signs included weight (kg), height (cm), body temperature (degree Celsius), heart rate (beats/min), respiratory rate (breaths/minute), systolic and diastolic blood pressure (mm Hg), body mass index (BMI) (kg/m^2). The criteria for clinically significant abnormal value for weight was decrease or increase of >=5% in body weight relative to Baseline. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values | The criteria for clinically significant abnormal ECG values were ventricular rate outlier (<50 bpm and decrease of >=25%, >100 bpm and increase of >=25%), PR outlier (increase of >=25% when PR >200 milliseconds (ms)), QRS outlier (increase of >=25% when QRS >100 ms), QT (new onset (in treatment period but not at Baseline) [>500 ms]), QT interval corrected by Bazett's formula (QTcB) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), QT interval corrected by Fridericia's formula (QTcF) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), new abnormal U waves, new ST segment changes, new T wave changes, new abnormal rhythm, new conduction abnormality were reported as categories. Only categories with data are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline QT Interval (QTcB) Effect | The 12-lead ECG was performed to obtain recordings of heart rate (QT interval) to analyze QTcB effect. | Baseline (Day -1) |
| PK/PD Relationship: POPPK Model Point Estimate for Slope of Linear Mixed Effects Model for Change in QTcB Interval Versus Delamanid Plasma Concentrations |
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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:
Negative urine pregnancy test for female participants who have reached menarche
Written informed consent/assent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melchor VG Frias, IV, MD | De La Salle Health Sciences Institute | Principal Investigator |
| Anjanette Reyes-De Leon, MD | Lung Center of the Philippines | Principal Investigator |
| Louvina van der Laan, MD | Brooklyn Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De La Salle Health Sciences Institute | Dasmariñas | Cavite | Philippines | |||
| Lung Center of the Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35404075 | Derived | Garcia-Prats AJ, Frias M, van der Laan L, De Leon A, Gler MT, Schaaf HS, Hesseling AC, Malikaarjun S, Hafkin J. Delamanid Added to an Optimized Background Regimen in Children with Multidrug-Resistant Tuberculosis: Results of a Phase I/II Clinical Trial. Antimicrob Agents Chemother. 2022 May 17;66(5):e0214421. doi: 10.1128/aac.02144-21. Epub 2022 Apr 11. |
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Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
Pediatric participants with a diagnosis of multidrug-resistant tuberculosis (MDR-TB) who were on therapy with an optimized background regimen (OBR) of anti-tuberculosis drugs and completed study 242-12-232 (NCT01856634) were enrolled in this extension study 242-12-233 to receive delamanid based on the participant's age and weight.
Participants took part in study at 3 investigative sites in Philippines and South Africa from July 20, 2013 to January 13, 2020. Participants received delamanid up to Day 182 in the treatment period and were followed up to Day 365 for safety and efficacy and up to Day 730 (Month 24) for treatment outcome.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 12 to 17 Years of Age | Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 milligrams (mg) (2x50 mg tablets), orally, twice daily (BID) plus optimized background regimen (OBR) up to Day 182. Participants continued to receive OBR up to Day 365. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2019 | Oct 22, 2020 |
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| Delamanid Pediatric Formulation (DPF) | Drug | Participants received delamanid as an extemporaneous suspension using the delamanid pediatric dispersible tablet formulation. Morning dose of the delamanid BID/once daily (QD) regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard meal. |
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| Optimized Background Regimen (OBR) | Drug | Selection and administration of the treatment medications (i.e. OBRs) was based on Search Results Web result with site links World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study Investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results. |
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| From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory assessments included parameters for serum chemistry, hematology and urinalysis along with adrenocorticotropic hormone, serum cortisol, free thyroxine, thyroid-stimulating hormone (TSH), and high sensitivity C-reactive protein cell count. The participants were categorized based on the clinically significant laboratory values as per protocol predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported. The normal ranges for those laboratory parameters were potassium 3.4 - 5.4 milliequivalents/liter (mEq/L), uric acid 3.9 - 8.2 mg/dL, partial thromboplastin time (PTT) 9.7 - 12.3 sec, platelet count 180 - 440 thousands platelets/μL. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Population Pharmacokinetic (POPPK) Model Point Estimate for Central Clearance (L) and Inter-compartmental Clearance (Q) of Delamanid | Central clearance is defined as plasma volume in the vascular compartment that is cleared of drug per unit of time. Inter-compartmental clearance is defined as a ratio of the drug's distribution rate between the central compartment and the peripheral compartments over its circulating concentration (L/hr). Population point estimates were based on POPPK analysis to find one measure each for both L and Q. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
| POPPK Model Point Estimate for Central Volume of Distribution (Vc) and Peripheral Volume of Distribution (Vp) of Delamanid | Vc is defined as the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. Vp is defined as the apparent volume needed to account for the total amount of drug in the body if the drug was evenly distributed throughout the body and in the same concentration as the site of sample collection such as peripheral venous plasma. Population point estimates were based on POPPK analysis to find one measure each for both Vc and Vp. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
| POPPK Model Point Estimate for Absorption Rate Constant (Ka) of Delamanid | Ka is defined as a measure of rate at which a drug enters into the circulatory system. Population point estimate for Ka was based on population PK analysis to find one measure. Population point estimates were based on POPPK analysis to find one measure for Ka. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
| POPPK Model Point Estimate for Absorption Lag Time (ALAG1) of Delamanid | ALAG1 is defined as the time delay prior to the commencement of drug absorption. Population point estimates were based on POPPK analysis to find one measure for ALAG1. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
The linear mixed effects model was applied to characterize the concentration-QTcB relationship of delamanid/DM-6705 to obtain population slope estimate. |
| Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
| Number of Participants With Treatment Outcome as Assessed by Principal Investigator | Treatment outcome was defined as favorable (cured and completed treatment) and unfavorable (lost to follow-up or died). | Month 24 |
| Number of Participants With Abnormal Chest X-ray | The data for the chest X-ray with abnormality, as assessed by investigator is reported. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Investigator-Assessed Signs and Symptoms of Tuberculosis | The following signs and symptoms of tuberculosis were assessed by the investigator: cough, fever, weight loss, failure to thrive, hemoptysis, dyspnea, chest pain, night sweats and loss of appetite. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Sputum Culture Conversion (SCC) | SCC was defined as a sputum specimen from a participant negative for growth of Mycobacterium tuberculosis (MTB), followed by at least one confirmatory negative sputum culture at least 27 days after the first negative sputum test and not followed by any sputum cultures positive for growth. | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
| Number of Participants With Palatability Score as Assessed by the Investigator | The palatability of the pediatric formulation was assessed using an age-appropriate visual hedonic scale and clinical assessment (Groups 3 and 4 only). The palatability result was based on 1 of 5 responses: 1=Dislike very much, 2=Dislike a little, 3=Neither liked nor disliked, 4=Like a little, 5=Like very much. Participants were categorized based on different scores. The data per the investigator score are reported. | Days 1, 28, 56 and 182 |
| Number of Participants With Palatability Score as Assessed by the Parent or Participant | The palatability of the pediatric formulation was assessed using an age-appropriate visual hedonic scale and clinical assessment (Groups 3 and 4 only). The palatability result was based on 1 of 5 responses: 1=Dislike very much, 2=Dislike a little, 3=Neither liked nor disliked, 4=Like a little, 5=Like very much. The data per parent/patient score are reported. Participants were categorized based on different scores. | Days 1, 28, 56 and 182 |
| Quezon City |
| National Capital Region |
| Philippines |
| Brooklyn Chest Hospital | Ysterplaat | Cape Town | South Africa |
| Group 2: 6 to 11 Years of Age |
Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| FG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| FG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Sample included participants who received any amount of investigational medicinal product (IMP) in this study, regardless of any protocol deviation or violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 12 to 17 Years of Age | Participants 12 to 17 years old (inclusive) received adult formulation of delamanid 100 mg (2x50 mg tablets), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| BG001 | Group 2: 6 to 11 Years of Age | Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| BG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| BG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With At Least One Treatment Emergent Adverse Event (TEAE) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant and that does not necessarily have a causal relationship with the treatment. A TEAE is defined as an AE that occurred after the administration of investigational medicinal product (IMP). | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Primary | Number of Participants With Abnormal Physical Examination Values | Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax; urogenital; audiometry assessment and visual assessment. Participants with abnormal values, as assessed by the investigator were reported. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. Overall number of participants analyzed are the participants with data available for analyses. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Primary | Number of Participants With Clinically Significant Abnormal Vital Sign Values | Vital signs included weight (kg), height (cm), body temperature (degree Celsius), heart rate (beats/min), respiratory rate (breaths/minute), systolic and diastolic blood pressure (mm Hg), body mass index (BMI) (kg/m^2). The criteria for clinically significant abnormal value for weight was decrease or increase of >=5% in body weight relative to Baseline. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. Overall number of participants analyzed are the participants with data available for analyses. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values | The criteria for clinically significant abnormal ECG values were ventricular rate outlier (<50 bpm and decrease of >=25%, >100 bpm and increase of >=25%), PR outlier (increase of >=25% when PR >200 milliseconds (ms)), QRS outlier (increase of >=25% when QRS >100 ms), QT (new onset (in treatment period but not at Baseline) [>500 ms]), QT interval corrected by Bazett's formula (QTcB) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), QT interval corrected by Fridericia's formula (QTcF) (new onset [>450, >480, >500 ms], increase of >=30 ms and <= 60 ms or increase of >60 ms), new abnormal U waves, new ST segment changes, new T wave changes, new abnormal rhythm, new conduction abnormality were reported as categories. Only categories with data are reported. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. Overall number of participants analyzed are the participants with data available for analyses. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Primary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Laboratory assessments included parameters for serum chemistry, hematology and urinalysis along with adrenocorticotropic hormone, serum cortisol, free thyroxine, thyroid-stimulating hormone (TSH), and high sensitivity C-reactive protein cell count. The participants were categorized based on the clinically significant laboratory values as per protocol predefined criteria. The categories with at least one participant with clinically significant value outside the normal range for laboratory assessments are reported. The normal ranges for those laboratory parameters were potassium 3.4 - 5.4 milliequivalents/liter (mEq/L), uric acid 3.9 - 8.2 mg/dL, partial thromboplastin time (PTT) 9.7 - 12.3 sec, platelet count 180 - 440 thousands platelets/μL. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Primary | Population Pharmacokinetic (POPPK) Model Point Estimate for Central Clearance (L) and Inter-compartmental Clearance (Q) of Delamanid | Central clearance is defined as plasma volume in the vascular compartment that is cleared of drug per unit of time. Inter-compartmental clearance is defined as a ratio of the drug's distribution rate between the central compartment and the peripheral compartments over its circulating concentration (L/hr). Population point estimates were based on POPPK analysis to find one measure each for both L and Q. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Population Pharmacokinetic (PK)/Pharmacodynamic (PD) analysis sample included all the participants with data available for PK/PD analysis. | Posted | Number | L/hr | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
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| Primary | POPPK Model Point Estimate for Central Volume of Distribution (Vc) and Peripheral Volume of Distribution (Vp) of Delamanid | Vc is defined as the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. Vp is defined as the apparent volume needed to account for the total amount of drug in the body if the drug was evenly distributed throughout the body and in the same concentration as the site of sample collection such as peripheral venous plasma. Population point estimates were based on POPPK analysis to find one measure each for both Vc and Vp. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Population PK/PD analysis sample included all the participants with data available for PK/PD analysis. | Posted | Number | liters (L) | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
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| Primary | POPPK Model Point Estimate for Absorption Rate Constant (Ka) of Delamanid | Ka is defined as a measure of rate at which a drug enters into the circulatory system. Population point estimate for Ka was based on population PK analysis to find one measure. Population point estimates were based on POPPK analysis to find one measure for Ka. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Population PK/PD analysis sample included all the participants with data available for PK/PD analysis. | Posted | Number | per hour (1/hr) | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
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| Primary | POPPK Model Point Estimate for Absorption Lag Time (ALAG1) of Delamanid | ALAG1 is defined as the time delay prior to the commencement of drug absorption. Population point estimates were based on POPPK analysis to find one measure for ALAG1. The exposure data were pooled across visits and participants to identify POPPK parameter estimates and were reported for delamanid. | Population PK/PD analysis sample included all the participants with data available for PK/PD analysis. | Posted | Number | hour (hr) | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
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| Secondary | Baseline QT Interval (QTcB) Effect | The 12-lead ECG was performed to obtain recordings of heart rate (QT interval) to analyze QTcB effect. | Population PK/PD analysis sample included all the participants with data available for PK/PD analysis. | Posted | Mean | 90% Confidence Interval | ms | Baseline (Day -1) |
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| Secondary | PK/PD Relationship: POPPK Model Point Estimate for Slope of Linear Mixed Effects Model for Change in QTcB Interval Versus Delamanid Plasma Concentrations | The linear mixed effects model was applied to characterize the concentration-QTcB relationship of delamanid/DM-6705 to obtain population slope estimate. | Population PK/PD analysis sample included all the participants with data available for PK/PD analysis. | Posted | Mean | 90% Confidence Interval | ms/[ng/mL] | Predose on Days 1, 56, 154, and 182, 210 and at any time point on Days 14, 98, 189, 196, 203, and 238 |
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| Secondary | Number of Participants With Treatment Outcome as Assessed by Principal Investigator | Treatment outcome was defined as favorable (cured and completed treatment) and unfavorable (lost to follow-up or died). | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. | Posted | Count of Participants | Participants | Month 24 |
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| Secondary | Number of Participants With Abnormal Chest X-ray | The data for the chest X-ray with abnormality, as assessed by investigator is reported. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Secondary | Number of Participants With Investigator-Assessed Signs and Symptoms of Tuberculosis | The following signs and symptoms of tuberculosis were assessed by the investigator: cough, fever, weight loss, failure to thrive, hemoptysis, dyspnea, chest pain, night sweats and loss of appetite. | The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation. | Posted | Count of Participants | Participants | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Secondary | Sputum Culture Conversion (SCC) | SCC was defined as a sputum specimen from a participant negative for growth of Mycobacterium tuberculosis (MTB), followed by at least one confirmatory negative sputum culture at least 27 days after the first negative sputum test and not followed by any sputum cultures positive for growth. | Data for SCC could not be collected due to the paucity of sputum production in the participants. | Posted | From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365) |
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| Secondary | Number of Participants With Palatability Score as Assessed by the Investigator | The palatability of the pediatric formulation was assessed using an age-appropriate visual hedonic scale and clinical assessment (Groups 3 and 4 only). The palatability result was based on 1 of 5 responses: 1=Dislike very much, 2=Dislike a little, 3=Neither liked nor disliked, 4=Like a little, 5=Like very much. Participants were categorized based on different scores. The data per the investigator score are reported. | Participants from the safety sample aged below 5 years (Groups 3 and 4) and who received any amount of IMP in this study, regardless of any protocol deviation or violation were analyzed for this outcome measure. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Count of Participants | Participants | Days 1, 28, 56 and 182 |
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| Secondary | Number of Participants With Palatability Score as Assessed by the Parent or Participant | The palatability of the pediatric formulation was assessed using an age-appropriate visual hedonic scale and clinical assessment (Groups 3 and 4 only). The palatability result was based on 1 of 5 responses: 1=Dislike very much, 2=Dislike a little, 3=Neither liked nor disliked, 4=Like a little, 5=Like very much. The data per parent/patient score are reported. Participants were categorized based on different scores. | Participants from the safety sample aged below 5 years (Groups 3 and 4) and who received any amount of IMP in this study, regardless of any protocol deviation or violation were analyzed for this outcome measure. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Count of Participants | Participants | Days 1, 28, 56 and 182 |
|
From the first dose of study drug up to the end of the Post-treatment Follow-up Period (Up to Day 365)
The Safety Sample included participants who received any amount of IMP in this study, regardless of any protocol deviation or violation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 12 to 17 Years of Age | Participants 12-17 years old (inclusive) received adult formulation of delamanid 100 mg (2x50 mg tablets), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG001 | Group 2: 6 to 11 Years of Age | Participants 6-11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. | 1 | 12 | 2 | 12 | 12 | 12 |
| EG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. | 1 | 12 | 5 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Conductive deafness | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vernal keratoconjunctivitis | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Ascariasis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Mumps | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Parasitic gastroenteritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Rubella | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Systemic viral infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood corticotrophin increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain In extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Butterfly rash | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sexual abuse | Social circumstances | MedDRA (22.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
|
Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2019 | Oct 22, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C516022 | OPC-67683 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Other |
|
| South Africa |
|
Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| OG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| Group 2: 6 to 11 Years of Age |
Participants 6 to 11 years old (inclusive) received adult formulation delamanid 50 mg (1x50 mg tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| OG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| OG002 | Group 3: 3 to 5 Years of Age | Participants 3 to 5 years old (inclusive) received 25 mg pediatric formulation of delamanid (DPF - suspension prepared using dispersible tablet), orally, BID plus OBR up to Day 182. Participants continued to receive OBR up to Day 365. |
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Delamanid |
| |||||
| Metabolite DM-6705 |
|
|
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
|
| OG003 | Group 4: Birth to 2 Years of Age | Participants from birth to 2 years old (inclusive) received DPF (suspension prepared using dispersible tablet) for 182 days plus OBR. Participants continued to receive OBR up to Day 365. The DPF dose was based on the participant's body weight during the baseline visit:
Delamanid dose was adjusted as needed for Group 4 participants based on the weight measurement at specified study visits [Visits 5 (Day 28), 7 (Day 56), 9 (Day 84), 11 (Day 126) and 12 (Day 154)]. |
|
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| Dislike a Little |
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| Neither Liked Nor Disliked |
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| Like a Little |
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| Like Very Much |
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| Dislike a Little |
|
| Neither Liked Nor Disliked |
|
| Like a Little |
|
| Like Very Much |
|
| Dislike a Little |
|
| Neither Liked Nor Disliked |
|
| Like a Little |
|
| Like Very Much |
|
| Dislike a Little |
|
| Neither Liked Nor Disliked |
|
| Like a Little |
|
| Like Very Much |
|
| Dislike a Little |
|
| Neither Liked Nor Disliked |
|
| Like a Little |
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| Like Very Much |
|
| Dislike a Little |
|
| Neither Liked Nor Disliked |
|
| Like a Little |
|
| Like Very Much |
|