MalariaPhase 1/2PQSAFETYNCT02535767
Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali
A Phase 1/2 study testing Primaquine in people with Malaria, run by University of California, San Francisco at 1 site in Mali.
Trial summary
The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which: Two or fewer participants (< 30%) experience hemolysis; No participant experiences a drug-related serious adverse event; and No participant requires a blood transfusion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Primaquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMali
- Study dates
- Aug 2015to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males ages 18- 50 (inclusive)
- Ability to swallow oral medication
- Informed consent
- Willing and able to participate in the study for 28 days
- For the G6PDd participants:
- G6PDd defined by Carestart 3 rapid diagnostic test or
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- The OSMMR2000 G6PD qualitative test
- For the G6PDn participants:
- G6PDn defined by Carestart 3 rapid diagnostic test or
- The OSMMR2000 G6PD qualitative test
Who cannot join
- Moderate to severe anemia (Hb < 10 g/dL)
- Malaria infection by blood smear
- Individuals with known positive HIV test
- Individuals with known positive hepatitis B test.
- Known allergy to study drugs
- Current use of medication (for tuberculosis, HIV, or any drugs that have hemolytic potential in G6PDd individuals including sulphonamides, dapsone, nitrofurantoin, nalidixic acid, ciprofloxacin, methylene blue, toluidine blue, phenazopyridine, and co-trimoxazole)
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- The individual is unwilling to abstain from the ingestion of grapefruit-containing products from 72 hours prior to the start of dosing until the study is complete
- Use of antimalarials within 2 weeks before contact with the study team as reported by the patient
- History of blood transfusion or a bleed of > 500 mLs within the last 3 months, as reported by the patient
- Reported history of high alcohol intake (> 14 units per week, each unit is equivalent to 10 g of alcohol (1 glass of wine or 1 bottle of beer or one shot of distilled spirits), within 6 months of study as reported by the patient
- Reported use of illicit drugs (marijuana, heroin, cocaine, methamphetamine) or dependence within 6 months of study, as reported by the patient
- Participants who vomit within 1 hour after administration of primaquine (will be removed from the analysis and will not count towards the total sample size, though they will be followed as any other enrolled individual)
- Already enrolled in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:
- Two or fewer participants (< 30%) experience hemolysis;
- No participant experiences a drug-related serious adverse event; and
- No participant requires a blood transfusion.
Read the detailed description
Purpose: The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:
- Two or fewer participants (< 30%) experience hemolysis;
- No participant experiences a drug-related serious adverse event; and
- No participant requires a blood transfusion.
Design:
- This is an open-label, phase 2, dose-adjustment study.
- The initial primaquine dose will be 0.40 mg/kg. Subsequent dose groups will be selected depending on the occurrence of adverse events in the previous dose group. Once the highest tolerable dose in G6PD-deficient (G6PDd) individuals is established, a control group of G6PD normal malaria-free men will be enrolled and evaluated under the highest tolerable dose of primaquine.
Study Population:
- Malian men aged 18-50 years without malaria infection.
- The majority of study participants will be G6PDd.
Study Size: This study will enroll 7 participants per dose group. If all dose groups are tested, this study will enroll approximately 28 participants.
Study visit and duration:
- Each participant will be followed for 28 days.
- Participants will be evaluated for hemolysis and adverse events on Days 1-10, 14, and 28 following their assigned primaquine dose.
Primary objective:
To measure the change in hemoglobin among G6PD deficient west-African men following a single low-dose of primaquine not to exceed 0.75 mg/kg.
Secondary objectives:
- To measure the occurrence of adverse events, graded by severity, at each primaquine dose among G6PD deficient men
- To measure the occurrence of markers of acute hemolytic anemia (AHA), at each primaquine dose among G6PD deficient men. AHA markers will include:
- Absolute and fractional change in hemoglobin on day 7 vs. baseline
- Urine color
- Reticulocyte count
- Bilirubin (both total and direct)
- Methemoglobin concentration
- Development of physical signs or symptoms of hemolytic anemia
- To compare the change in hemoglobin, frequency and severity of adverse events, and occurrence of markers of AHA between G6PD deficient and non-deficient participants receiving the highest tolerable primaquine dose
- To measure G6PD enzyme activity (semiquantitative testing, U / gHb)
- To measure the pharmacokinetics of primaquine, carboxyprimaquine, and other metabolites according to plasma concentrations.
- To genotype participant blood samples for cytochrome P450 2D6 (CYP2D6) single nucleotide polymorphisms (SNPs), to determine if potential hemolysis in G6PDd individuals is affected by CYP2D6 metabolizer status (e.g. weak metabolizers and/or intermediate metabolizers)
- Conditions
- Malaria
- Being tested
- Primaquine
- Keywords
- Primaquine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimaquineDrug
A single low dose of primaquine will be crushed and dissolved in water, and administered in weight-based doses.
| Study group | Role | What they receive |
|---|---|---|
| A: 0.40 mg/kg PQ G6PDd | Experimental | 0.40 mg/kg of primaquine (as a single dose) in G6PD-deficient individuals Receives: Drug: Primaquine |
| B: PQ in G6PDd | Experimental | A single dose of primaquine in G6PD-deficient men, exact dose to be decided by DSMB based on findings in previous dose group. The minimum change in dose from the last study dose is 0.05 mg/kg, and the maximum change is 0.20 mg/kg of primaquine). Dose is not to exceed 0.75 mg/kg primaquine. Receives: Drug: Primaquine |
| C: PQ in G6PDd | Experimental | A single dose of primaquine in G6PD-deficient men, exact dose to be decided by DSMB based on findings in previous dose group. The minimum change in dose from the last study dose is 0.05 mg/kg, and the maximum change is 0.20 mg/kg of primaquine). Dose is not to exceed 0.75 mg/kg primaquine. Receives: Drug: Primaquine |
| D: PQ G6PDn | Experimental | A single dose of primaquine in G6PD-normal men, at the highest tolerable dose determined by the DSMB, from previous dose groups. Receives: Drug: Primaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: the change in hemoglobin concentration from baseline levels following a single low-dose of primaquine not to exceed 0.75 mg/kg.
Measured: Between day 0 and day 10.
Secondary outcomes (12)
To measure the occurrence of adverse events, graded by severity, at each primaquine dose among G6PD deficient men
Severity:
- = mild
- = moderate
- = severe
- = life threatening
Measured: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To measure the occurrence of absolute and fractional change in hemoglobin concentration (g/dL) on day 7 vs. baseline at each primaquine dose among G6PD deficient men, in comparison with G6PD normal men
Measured: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To measure the occurrence of reticulocytosis (by microscopic quantification of reticulocytes stained with brilliant cresyl blue / 1,000 RBCs) on each day of followup, at each primaquine dose, among G6PD deficient men, in comparison with G6PD normal men
Measured: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To monitor methemoglobin levels (%) on each day of followup, at each primaquine dose among G6PD deficient men, in comparison with G6PD normal men
Use of a Masimo Rad-57 pulse oximeter that measures methemoglobin levels non-invasively, based on absorption of light through the fingertip.
Measured: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To determine G6PD enzyme activity (semiquantitative testing, U/g Hb)
Semiquantitative testing will be performed on frozen blood samples to determine G6PD activity on day of enrolment
Measured: Day 0
Area Under Curve (AUC) for primaquine
Pharmacokinetic analysis of plasma concentration of primaquine at all sampled timepoints
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for primaquine
Pharmacokinetic analysis of plasma concentration of primaquine at all sampled timepoints
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Area Under Curve (AUC) for carboxyprimaquine
Pharmacokinetic analysis of plasma concentration of carboxyprimaquine
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for carboxyprimaquine
Pharmacokinetic analysis of plasma concentration of carboxyprimaquine
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Area Under Curve (AUC) for select minor metabolites of primaquine
Pharmacokinetic analysis of plasma concentration of metabolites of primaquine, exact metabolites to be determined by ongoing in vivo studies (including 5-hydroxyprimaquine)
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for select minor metabolites of primaquine
Pharmacokinetic analysis of plasma concentration of metabolites of primaquine, exact metabolites to be determined by ongoing in vivo studies (including 5-hydroxyprimaquine)
Measured: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Cytochrome P450 (CYP) 2D6 genotyping
To determine whether a correlation between CYP 2D6 metabolism (weak metabolizer, intermediate metabolizer, normal metabolizer, ultrarapid metabolizer) and hemolysis exists.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Radboud University Medical Center, University of Mississippi Medical Center, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Roland Gosling, PhD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535767
- Sponsor's protocol ID
- 14-14495
- Acronym
- PQSAFETY
- Status last verified
- Feb 2017
- First submitted
- 7 Aug 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chotsiri P, Mahamar A, Diawara H, Fasinu PS, Diarra K, Sanogo K, Bousema T, Walker LA, Brown JM, Dicko A, Gosling R, Chen I, Tarning J. Population pharmacokinetics of primaquine and its metabolites in African males. Malar J. 2024 May 21;23(1):159. doi: 10.1186/s12936-024-04979-y.
PubMed 38773528Chen I, Diawara H, Mahamar A, Sanogo K, Keita S, Kone D, Diarra K, Djimde M, Keita M, Brown J, Roh ME, Hwang J, Pett H, Murphy M, Niemi M, Greenhouse B, Bousema T, Gosling R, Dicko A. Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria: An Open-Label, Phase 1, Dose-Adjustment Trial. J Infect Dis. 2018 Mar 28;217(8):1298-1308. doi: 10.1093/infdis/jiy014.
PubMed 29342267
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining a Tolerable Dose of Primaquine in G6PD-deficient Persons Without Malaria in Mali
- ClinicalTrials.gov ID
- NCT02535767
- Acronym / sponsor ID
- PQSAFETY / 14-14495
- Conditions
- Malaria
- Keywords
- Primaquine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Malaria Research and Training Center, Bamako, Mali, Radboud University Medical Center, University of Mississippi Medical Center, Bill and Melinda Gates Foundation
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
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 determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:
- Two or fewer participants (< 30%) experience hemolysis;
- No participant experiences a drug-related serious adverse event; and
- No participant requires a blood transfusion.
Detailed description
Purpose: The purpose of this study is to determine the highest tolerable dose of primaquine within 0.75 mg/kg. A tolerable dose is defined as one in which:
- Two or fewer participants (< 30%) experience hemolysis;
- No participant experiences a drug-related serious adverse event; and
- No participant requires a blood transfusion.
Design:
- This is an open-label, phase 2, dose-adjustment study.
- The initial primaquine dose will be 0.40 mg/kg. Subsequent dose groups will be selected depending on the occurrence of adverse events in the previous dose group. Once the highest tolerable dose in G6PD-deficient (G6PDd) individuals is established, a control group of G6PD normal malaria-free men will be enrolled and evaluated under the highest tolerable dose of primaquine.
Study Population:
- Malian men aged 18-50 years without malaria infection.
- The majority of study participants will be G6PDd.
Study Size: This study will enroll 7 participants per dose group. If all dose groups are tested, this study will enroll approximately 28 participants.
Study visit and duration:
- Each participant will be followed for 28 days.
- Participants will be evaluated for hemolysis and adverse events on Days 1-10, 14, and 28 following their assigned primaquine dose.
Primary objective:
To measure the change in hemoglobin among G6PD deficient west-African men following a single low-dose of primaquine not to exceed 0.75 mg/kg.
Secondary objectives:
- To measure the occurrence of adverse events, graded by severity, at each primaquine dose among G6PD deficient men
- To measure the occurrence of markers of acute hemolytic anemia (AHA), at each primaquine dose among G6PD deficient men. AHA markers will include:
- Absolute and fractional change in hemoglobin on day 7 vs. baseline
- Urine color
- Reticulocyte count
- Bilirubin (both total and direct)
- Methemoglobin concentration
- Development of physical signs or symptoms of hemolytic anemia
- To compare the change in hemoglobin, frequency and severity of adverse events, and occurrence of markers of AHA between G6PD deficient and non-deficient participants receiving the highest tolerable primaquine dose
- To measure G6PD enzyme activity (semiquantitative testing, U / gHb)
- To measure the pharmacokinetics of primaquine, carboxyprimaquine, and other metabolites according to plasma concentrations.
- To genotype participant blood samples for cytochrome P450 2D6 (CYP2D6) single nucleotide polymorphisms (SNPs), to determine if potential hemolysis in G6PDd individuals is affected by CYP2D6 metabolizer status (e.g. weak metabolizers and/or intermediate metabolizers)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: 0.40 mg/kg PQ G6PDd | Experimental | Drug: Primaquine0.40 mg/kg of primaquine (as a single dose) in G6PD-deficient individuals |
| B: PQ in G6PDd | Experimental | Drug: PrimaquineA single dose of primaquine in G6PD-deficient men, exact dose to be decided by DSMB based on findings in previous dose group. The minimum change in dose from the last study dose is 0.05 mg/kg, and the maximum change is 0.20 mg/kg of primaquine). Dose is not to exceed 0.75 mg/kg primaquine. |
| C: PQ in G6PDd | Experimental | Drug: PrimaquineA single dose of primaquine in G6PD-deficient men, exact dose to be decided by DSMB based on findings in previous dose group. The minimum change in dose from the last study dose is 0.05 mg/kg, and the maximum change is 0.20 mg/kg of primaquine). Dose is not to exceed 0.75 mg/kg primaquine. |
| D: PQ G6PDn | Experimental | Drug: PrimaquineA single dose of primaquine in G6PD-normal men, at the highest tolerable dose determined by the DSMB, from previous dose groups. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males ages 18- 50 (inclusive)
- Ability to swallow oral medication
- Informed consent
- Willing and able to participate in the study for 28 days
- G6PDd defined by Carestart 3 rapid diagnostic test or
Key exclusion criteria (13 listed)
- Moderate to severe anemia (Hb < 10 g/dL)
- Malaria infection by blood smear
- Individuals with known positive HIV test
- Individuals with known positive hepatitis B test.
- Known allergy to study drugs
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 |
|---|---|---|
| PrimaquineA single low dose of primaquine will be crushed and dissolved in water, and administered in weight-based doses. | Drug | A: 0.40 mg/kg PQ G6PDd, B: PQ in G6PDd, C: PQ in G6PDd, D: PQ G6PDn |
Primary outcome
Primary outcome: the change in hemoglobin concentration from baseline levels following a single low-dose of primaquine not to exceed 0.75 mg/kg.
Time frame: Between day 0 and day 10.
12 secondary outcomes
To measure the occurrence of adverse events, graded by severity, at each primaquine dose among G6PD deficient men
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To measure the occurrence of absolute and fractional change in hemoglobin concentration (g/dL) on day 7 vs. baseline at each primaquine dose among G6PD deficient men, in comparison with G6PD normal men
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To measure the occurrence of reticulocytosis (by microscopic quantification of reticulocytes stained with brilliant cresyl blue / 1,000 RBCs) on each day of followup, at each primaquine dose, among G6PD deficient men, in comparison with G6PD normal men
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To monitor methemoglobin levels (%) on each day of followup, at each primaquine dose among G6PD deficient men, in comparison with G6PD normal men
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 28
To determine G6PD enzyme activity (semiquantitative testing, U/g Hb)
Time frame: Day 0
Area Under Curve (AUC) for primaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for primaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Area Under Curve (AUC) for carboxyprimaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for carboxyprimaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Area Under Curve (AUC) for select minor metabolites of primaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Maximal concentration (Cmax) for select minor metabolites of primaquine
Time frame: Hours 1, 2, 4, 6, 8, and 24 after primaquine administration
Cytochrome P450 (CYP) 2D6 genotyping
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 38773528Chotsiri P, Mahamar A, Diawara H, Fasinu PS, Diarra K, Sanogo K, Bousema T, Walker LA, Brown JM, Dicko A, Gosling R, Chen I, Tarning J. Population pharmacokinetics of primaquine and its metabolites in African males. Malar J. 2024 May 21;23(1):159. doi: 10.1186/s12936-024-04979-y.
- Derived from this study: PubMed 29342267Chen I, Diawara H, Mahamar A, Sanogo K, Keita S, Kone D, Diarra K, Djimde M, Keita M, Brown J, Roh ME, Hwang J, Pett H, Murphy M, Niemi M, Greenhouse B, Bousema T, Gosling R, Dicko A. Safety of Single-Dose Primaquine in G6PD-Deficient and G6PD-Normal Males in Mali Without Malaria: An Open-Label, Phase 1, Dose-Adjustment Trial. J Infect Dis. 2018 Mar 28;217(8):1298-1308. doi: 10.1093/infdis/jiy014.
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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.
Roland Gosling, PhD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Primaquine in people with Malaria, run by University of California, San Francisco at 1 site in Mali.
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 10 inclusion and 13 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome: the change in hemoglobin concentration from baseline levels following a single low-dose of primaquine not to exceed 0.75 mg/kg. (time frame: Between day 0 and day 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535767, which also lists 2 linked publications.
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 6 Feb 2017.