TuberculosisPhase 2NCT01131351
Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
A Phase 2 study testing Delamanid and Optimized Background Regimen (OBR) in people with Tuberculosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is: To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Delamanid and Optimized Background Regimen (OBR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Feb 2010to 12 May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide written, informed consent prior to all trial-related procedures
- Male or female participants aged between 18 and 64 years, inclusive.
- Able to produce sputum for mycobacterium culture or able to obtain sputum produced through Induction.
- At least three sputum mycobacterium cultures positive for MTB with in-vitro resistance to isoniazid and rifampicin during the previous 270 days (9 months) despite treatment with first and second line anti-TB drugs, including one positive culture within the previous 60 days from the time of sputum collection, prior to date of screening initiation [defined as the date the informed consent form (ICF) is signed and screening begins].
- Sputum mycobacterial culture positive for MTB with in-vitro susceptibility to at least one anti-TB medication within the previous 60 days prior to the date of screening initiation.
- Participant judged by the investigator to have potential for clinical benefit from OPC-67683 exposure.
- Female participants of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control (for example, two of the following precautions: tubal ligation, vaginal diaphragm, intrauterine device, oral contraceptives, contraceptive implant, combined hormonal patch, combined injectable contraceptive or depot-medroxyprogesterone acetate) throughout the participation in the trial and for 22 weeks after last dose (to cover duration of ovulation).
- Male participant must agree to use an adequate method of contraception (double barrier) throughout the participation in the trial and for 30 weeks after last dose (to cover duration of spermatogenesis).
Who cannot join
- A history of allergy to any nitro-imidazoles or nitro-imidazole derivatives at any time.
- Use of the medications in Section 4.1 including: use of amiodarone at any time during the previous 12 months, use of other antiarrhythmics for the previous 30 days, as well as use of certain antidepressants, anti-histamines, any macrolides, for the previous 14 days.
- Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels ~265 micromoles (μmol)/L or hepatic impairment characterized by alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory reference range.
- Current clinically relevant changes in the Screening electrocardiogram (ECG) such as any atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in both male and female participants), or of the QT interval with Fridericia's correction (QTcF) interval over 450 msec in male participants and over 470 msec in female participants.
- Current clinically relevant cardiovascular disorder such as heart failure, coronary heart disease, uncontrolled or poorly controlled hypertension, arrhythmia, tachyarrhythmia or status after myocardial infarction.
- For participants with human immunodeficiency virus (HIV) infection, helper/inducer T-lymphocyte (CD4 cell) count < 350/mm^3 or on treatment with anti-retroviral medication for HIV infection.
- Karnofsky score < 50%.
- Any current diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Lithuania2 sites
Hospital for Tuberculosis and Lung Diseases
Šiauliai, LT-76231
National Tuberculosis and Infectious Diseases University Hospital
Vilnius, LT-10214
Latvia1 site
Infectology Center of Latvia - Clinic of Tuberculosis and Lung Diseases
Ogre, LV 5015
About this study
Official title: A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients With Pulmonary Multidrug-Resistant Tuberculosis Refractory to Conventional Treatment
The purpose of this study is:
- To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR).
- To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.
- Conditions
- Tuberculosis
- Being tested
- Delamanid, Optimized Background Regimen (OBR)
- Keywords
- MDR-TB, Dose Escalation, Phase II, Open Label, Non Controlled, Pulmonary Multidrug-Resistant Tuberculosis (MDR TB)
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelamanidDrug
Also called OPC-67683
OPC-67683 film-coated tablets
Optimized Background Regimen (OBR)Drug
OBR was selected at the discretion of the study investigator and included at least 2 anti-TB medications based on World Health Organization (WHO's) guidelines for the programmatic management of drug-resistant TB. Study investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.
| Study group | Role | What they receive |
|---|---|---|
| Delamanid 250 mg BID+ OBR | Experimental | Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks. Receives: Drug: Delamanid; Drug: Optimized Background Regimen (OBR) |
| Delamanid 300 mg BID+ OBR | Experimental | Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks. Receives: Drug: Delamanid; Drug: Optimized Background Regimen (OBR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Vital signs included body weight [kilogram (kg)], body temperature [degree Celsius (°C)], heart rate [beats per minute (BPM)], respiratory rate (breaths/minute), systolic and diastolic blood pressure [millimeter of mercury (mmHg)]. The criteria for clinically significant abnormal value were: body weight (kg): increase >=5% or decrease >=5%; body temperature (°C): >=38.5°C and increase of >=1.1°C; heart rate (BPM): >=120 bpm and increase of >=15 bpm, or <=60 bpm and decrease of >=15 bpm; systolic blood pressure (mmHg): >=160 mmHg and increase of >=20 mmHg, or <=90 mmHg and decrease of >=20 mmHg; diastolic blood pressure (mmHg): >=105 mmHg and increase of >=15 mmHg, or <=50 mmHg and decrease of >=15 mmHg; respiration rate (breaths per minute) >30 breaths per minute. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported.
Measured: Up to approximately 40 weeks
Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
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. Baseline was defined as the average of the ECGs taken at Day -1. Only categories with data for potentially clinically significant abnormal ECG values are reported.
Measured: Up to approximately 40 weeks
Percentage of Participants With Potentially Clinically Significant Laboratory Values
Clinical laboratory tests included hematology, coagulation, chemistry, and urinalysis. 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.
Measured: Up to approximately 40 weeks
Percentage of Participants With Abnormal Audiometry Assessment Values
Measured: Up to approximately 40 weeks
Percentage of Participants With Abnormal Visual Acuity Assessment Values
Measured: Up to approximately 40 weeks
Percentage of Participants Taking Concomitant Anti-Tuberculosis (TB) Medication During the Trial
Measured: Up to approximately 40 weeks
Percentage of Participants Taking Concomitant (Excluding Anti-TB) Medication During the Trial
Measured: Up to approximately 40 weeks
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator.
Measured: Up to approximately 40 weeks
Percentage of Participants With Immediately Reportable Events (IREs)
An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-participant hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The following were considered as IREs- serious adverse events (SAEs), pregnancies in trial participants or their partners, and all events involving overdose, misuse and abuse.
Measured: Up to approximately 40 weeks
Cmax: Maximal Peak Plasma Concentration for Delamanid
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid
AUC0-24h was calculated as 2×AUC0-12h.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (Cmax): Ratio of Accumulation for Cmax of Delamanid
Ratio of accumulation for Cmax was assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (AUC): Ratio of Accumulation for AUC of Delamanid
Ratio of accumulation for AUC was assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Secondary outcomes (8)
Cmax: Maximal Peak Plasma Concentration for Delamanid Metabolites
The primary metabolites of delamanid are DM-6704, DM-6705 and DM-6706.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid Metabolites
The primary metabolites of delamanid are DM-6704, DM-6705 and DM-6706.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid Metabolites
The primary metabolites of delamanid are DM-6704, DM-6705 and DM-6706.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (Cmax): Ratios of Accumulation for Cmax for Delamanid Metabolites
The primary metabolites of delamanid are DM-6704, DM-6705 and DM-6706. Ratio of accumulation for Cmax was planned to be assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (AUC): Ratios of Accumulation for AUC for Delamanid Metabolites
The primary metabolites of delamanid are DM-6704, DM-6705 and DM-6706. Ratio of accumulation for AUC was planned to be assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1. Limited metabolite exposure on Day 1 did not allow for estimation of Rac for metabolites.
Measured: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Percentage of Participants With Sputum Culture Conversion by Mycobacteria Growth Indicator Tube (MGIT) at Day 168
Sputum culture conversion was evaluated using the MGIT culture system. A participant was classified as demonstrating a sputum culture conversion if he/she achieved two consecutive sputum cultures negative for growth of Mycobacterium tuberculosis at least 28 days apart after his/her last sputum culture positive for growth and not followed by any sputum specimens positive for growth.
Measured: Day 168 (Week 24)
Percentage of Participants With Sputum Culture Conversion on Solid Mycobacterial Culture Media at Day 168
Sputum culture status was determined using solid mycobacterial culture media and measuring colony counts per milliliter of sputum. The unit for colony counts: log10 colony-forming unit (CFU)/mL. A participant was classified as demonstrating a sputum culture conversion if he/she achieved two consecutive sputum cultures negative for growth of Mycobacterium tuberculosis at least 28 days apart after his/her last sputum culture positive for growth and not followed by any sputum specimens positive for growth.
Measured: Day 168 (Week 24)
Mean Change From Baseline in Time to Culture Positivity Using MGIT
The value for time to positivity was defined (in days) as the time interval from inoculation until a positive signal was detected for MTB on sputum culture in the MGIT system during the routine 42 day incubation period. Time to positivity analysis was based on the corresponding qualitative sputum results of positive and negative sputum cultures in days of the initial positive signal for a culture from the MGIT system. Mean is reported for Baseline and mean change from baseline is reported for Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112, 126, 140, 154, 168, 182, 196, 224, 252, and 280. Baseline is Day -2 and -1. Mean time to culture positivity at Baseline was defined as the average of Day -2 and Day -1 values, if the cultures on both days were positive; and if only one culture was positive, the value for the positive culture was used as baseline.
Measured: Baseline and Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112, 126, 140, 154, 168, 182, 196, 224, 252, and 280
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study start19 Feb 2010
- Primary completion12 May 2011
- Study completion12 May 2011
Why it stopped: The study was terminated early due to lack of efficacy after 10 participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131351
- Sponsor's protocol ID
- 242-08-210
- Other IDs
- 2009-014944-13, 2009
- Status last verified
- Oct 2021
- First submitted
- 25 May 2010
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims prespecified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients With Pulmonary Multidrug-Resistant Tuberculosis Refractory to Conventional Treatment
- ClinicalTrials.gov ID
- NCT01131351
- Acronym / sponsor ID
- 242-08-210
- Conditions
- Tuberculosis
- Keywords
- MDR-TB, Dose Escalation, Phase II, Open Label, Non Controlled, Pulmonary Multidrug-Resistant Tuberculosis (MDR TB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to lack of efficacy after 10 participants enrolled.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2010 (actual)
- Primary completion
- 12 May 2011 (actual)
- Study completion
- 12 May 2011 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR).
- To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delamanid 250 mg BID+ OBR | Experimental | Drug: Delamanid, Drug: Optimized Background Regimen (OBR)Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks. |
| Delamanid 300 mg BID+ OBR | Experimental | Drug: Delamanid, Drug: Optimized Background Regimen (OBR)Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provide written, informed consent prior to all trial-related procedures
- Male or female participants aged between 18 and 64 years, inclusive.
- Able to produce sputum for mycobacterium culture or able to obtain sputum produced through Induction.
- At least three sputum mycobacterium cultures positive for MTB with in-vitro resistance to isoniazid and rifampicin during the previous 270 days (9 months) despite treatment with first and second line anti-TB drugs, including one positive culture within the previous 60 days from the time of sputum collection, prior to date of screening initiation [defined as the date the informed consent form (ICF) is signed and screening begins].
- Sputum mycobacterial culture positive for MTB with in-vitro susceptibility to at least one anti-TB medication within the previous 60 days prior to the date of screening initiation.
Key exclusion criteria (8 listed)
- A history of allergy to any nitro-imidazoles or nitro-imidazole derivatives at any time.
- Use of the medications in Section 4.1 including: use of amiodarone at any time during the previous 12 months, use of other antiarrhythmics for the previous 30 days, as well as use of certain antidepressants, anti-histamines, any macrolides, for the previous 14 days.
- Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels ~265 micromoles (μmol)/L or hepatic impairment characterized by alanine aminotransferase (ALT) and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory reference range.
- Current clinically relevant changes in the Screening electrocardiogram (ECG) such as any atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in both male and female participants), or of the QT interval with Fridericia's correction (QTcF) interval over 450 msec in male participants and over 470 msec in female participants.
- Current clinically relevant cardiovascular disorder such as heart failure, coronary heart disease, uncontrolled or poorly controlled hypertension, arrhythmia, tachyarrhythmia or status after myocardial infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DelamanidAlso: OPC-67683OPC-67683 film-coated tablets | Drug | Delamanid 250 mg BID+ OBR, Delamanid 300 mg BID+ OBR |
| Optimized Background Regimen (OBR)OBR was selected at the discretion of the study investigator and included at least 2 anti-TB medications based on World Health Organization (WHO's) guidelines for the programmatic management of drug-resistant TB. Study investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results. | Drug | Delamanid 250 mg BID+ OBR, Delamanid 300 mg BID+ OBR |
Primary outcome
Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Time frame: Up to approximately 40 weeks
Vital signs included body weight [kilogram (kg)], body temperature [degree Celsius (°C)], heart rate [beats per minute (BPM)], respiratory rate (breaths/minute), systolic and diastolic blood pressure [millimeter of mercury (mmHg)]. The criteria for clinically significant abnormal value were: body weight (kg): increase >=5% or decrease >=5%; body temperature (°C): >=38.5°C and increase of >=1.1°C; heart rate (BPM): >=120 bpm and increase of >=15 bpm, or <=60 bpm and decrease of >=15 bpm; systolic blood pressure (mmHg): >=160 mmHg and increase of >=20 mmHg, or <=90 mmHg and decrease of >=20 mmHg; diastolic blood pressure (mmHg): >=105 mmHg and increase of >=15 mmHg, or <=50 mmHg and decrease of >=15 mmHg; respiration rate (breaths per minute) >30 breaths per minute. Only categories with data for potentially clinically significant abnormal vital sign parameter values are reported.
Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
Time frame: Up to approximately 40 weeks
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. Baseline was defined as the average of the ECGs taken at Day -1. Only categories with data for potentially clinically significant abnormal ECG values are reported.
Percentage of Participants With Potentially Clinically Significant Laboratory Values
Time frame: Up to approximately 40 weeks
Clinical laboratory tests included hematology, coagulation, chemistry, and urinalysis. 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.
Percentage of Participants With Abnormal Audiometry Assessment Values
Time frame: Up to approximately 40 weeks
Percentage of Participants With Abnormal Visual Acuity Assessment Values
Time frame: Up to approximately 40 weeks
Percentage of Participants Taking Concomitant Anti-Tuberculosis (TB) Medication During the Trial
Time frame: Up to approximately 40 weeks
Percentage of Participants Taking Concomitant (Excluding Anti-TB) Medication During the Trial
Time frame: Up to approximately 40 weeks
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 40 weeks
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the investigator.
Percentage of Participants With Immediately Reportable Events (IREs)
Time frame: Up to approximately 40 weeks
An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-participant hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above. The following were considered as IREs- serious adverse events (SAEs), pregnancies in trial participants or their partners, and all events involving overdose, misuse and abuse.
Cmax: Maximal Peak Plasma Concentration for Delamanid
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
AUC0-24h was calculated as 2×AUC0-12h.
Rac (Cmax): Ratio of Accumulation for Cmax of Delamanid
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Ratio of accumulation for Cmax was assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1.
Rac (AUC): Ratio of Accumulation for AUC of Delamanid
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Ratio of accumulation for AUC was assessed on Days 14, 28, 56, 112 and 196 with respect to Day 1.
8 secondary outcomes
Cmax: Maximal Peak Plasma Concentration for Delamanid Metabolites
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Tmax: Time to Reach Maximal Peak Plasma Concentration for Delamanid Metabolites
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
AUC0-24h: Area Under the Plasma Concentration-Time Curve From 0 To 24 Hours for Delamanid Metabolites
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (Cmax): Ratios of Accumulation for Cmax for Delamanid Metabolites
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Rac (AUC): Ratios of Accumulation for AUC for Delamanid Metabolites
Time frame: At 24 hours post dose on Days 1, 14, 28, 56, 112 and 196
Percentage of Participants With Sputum Culture Conversion by Mycobacteria Growth Indicator Tube (MGIT) at Day 168
Time frame: Day 168 (Week 24)
Percentage of Participants With Sputum Culture Conversion on Solid Mycobacterial Culture Media at Day 168
Time frame: Day 168 (Week 24)
Mean Change From Baseline in Time to Culture Positivity Using MGIT
Time frame: Baseline and Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112, 126, 140, 154, 168, 182, 196, 224, 252, and 280
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims prespecified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delamanid and Optimized Background Regimen (OBR) in people with Tuberculosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Lithuania, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs (time frame: Up to approximately 40 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.