Drug CombinationPhase 1NCT02568098

Pharmacokinetic and Mosquito-Lethal Effects of Ivermectin (IVM), Primaquine (PQ), Dihydroartemisinin-Piperaquine (DHA-PQP) and Albendazole (ABZ) in Healthy Subjects

A Phase 1 study testing IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ, PQ and DHA-PQP and PQ and DHA-PQP in people with Drug Combination and Pharmacokinetics, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Drug Combination, Pharmacokinetics, Healthy
What is being tested?: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ, PQ and DHA-PQP and PQ and DHA-PQP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteThailand
Study dates: Oct 2015to Dec 2016
Phase: Phase 1
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
Males and Females non-smoker aged between 18 years to 60 years.
Males and Females weight between 36-75 kilograms.
A female is eligible to enter and participate in this study if she is:
of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 milli-International unit (mIU/mL) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy

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or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures
A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
Provide a signed and dated written informed consent prior to study participation.
Normal electrocardiogram (ECG) with QTc <450 msec.
Willingness and ability to comply with the study protocol for the duration of the trial.

Who cannot join

Females who are pregnant, trying to get pregnant, or are lactating.
The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia) or with a family history of sudden cardiac death.
A creatinine clearance (CLcr) <70 mL/min as determined by Cockcroft-Gault equation:
CLcr (mL/min) = (140 - age) Wt / (72 Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].

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History of alcohol or substance abuse or dependence within 6 months of the study.
Use of prescription (especially cytochrome P450 3A4 (CYP3A4) inhibitors or inducers) or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Plasma donation during the study is not acceptable.
Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 upper limit of normal (ULN)
Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
Abnormal methaemoglobin level.
History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 3 months.
Subject who received quinacrine in last 30 days.
The subject is unwilling to abstain from the consumption of vitamin C 24 hours before and after drug ingestion.
History of travel to West or Central Africa, unless it can be verified that subject does not have Loa loa infection.
G6PD deficient detected by Beutler's dye test.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Tropical Medicine
Bangkok, 10400

Other trials in Thailand

About this study

Official title: Open-Label Study to Evaluate Safety, Tolerability, Potential Pharmacokinetic Interactions and Mosquito-Lethal Effects of Orally Administered Ivermectin, Primaquine, Dihydroartemisinin-Piperaquine, and Albendazole in Healthy Adult Subjects

Primary Objective

To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects.

Secondary Objectives

To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and ABZ in healthy adult subjects.
To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.
To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM, ABZ and their metabolites.
To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against Anopheles dirus and Anopheles minimus.
To determine if IVM concentrations in venous blood differs from capillary blood.

Read the detailed description

This is an open-label, sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects. These 16 subjects have previously participated in either study:

Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered Primaquine (PQ) and Dihydroartemisinin-Piperaquine (DHA-PQP) in Healthy Adult Subjects (TMEC 12-004 (OxTREC ref. 58-11)) or study
Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine (CQ) and piperaquine (PQ) in healthy Thai subjects (TMEC 14-022 (OxTREC ref. 39-14)) or
subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)".

The study team will use the results of DHA-PQP regimen of the subjects from the above mentioned studies to compare with combination regimens in this study. This is to avoid unnecessary exposure of Subjects from (TMEC 12-004 (OxTREC ref. 58-11)) and (TMEC 14-022 (OxTREC ref. 39-14)) to the subjects. In addition, subjects have previously been tested for G6PD deficiency during screening process from the above mentioned study with result showed as normal. Therefore, a G6PD deficiency test is not needed. A G6PD deficiency test is needed for subjects who not previously participated in study subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)" for this study.

Subjects will be admitted in the inpatient ward to receive single dose of 6 regimens (regimens 1-4 and 8-9) described below. Every subject will have at least 6 admissions in the hospital.

1: IVM (400 μg/kg) via 6 mg tabs, w-o** >4wks; 2: IVM (400 μg/kg)+PQ (15 mg): 2 tabs), w-o >4wks; 3: IVM (400 μg/kg)+DHA-PQP (40mg/320 mg): 3 tabs), w-o >8wks; 4: IVM (400 μg/kg)+DHA-PQP+PQ, w-o >8wks; 5*#: PQ (15 mg): 2 tabs, w-o > 2wks; 6#: DHA-PQP (40mg/320 mg): 3 tabs, w-o >8wks; 7*#: DHA-PQP (40mg/320 mg): 3 tabs +PQ (15 mg): 2 tabs, w-o >8wks; 8: ABZ (200 mg) 2 tabs, w-o >2wks; 9: IVM (400 μg/kg)+DHA-PQP (40mg/320 mg): 3 tabs+PQ (15 mg): 2 tabs +ABZ (400 mg): 1 tab, w-o >8wks

The subjects from TMEC-14-022 (OxTREC ref. 39-14) will have two additional admissions to receive two additional regimen PQ, and DHA-PQP with PQ

# Subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)" will have three additional admissions to receive three additional regimens PQ, DHA-PQP, and DHA-PQP with PQ.

**w-o = washout period

Conditions: Drug Combination, Pharmacokinetics, Healthy
Being tested: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ, PQ and DHA-PQP and PQ, DHA-PQP
Keywords: Drug combination, Ivermectin, Primaquine, Dihydroartemisinin-Piperaquine, Albendazole, Pharmacokinetics, Mosquito-Lethal Effect, Healthy adult subject

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQDrug
Regimen 1: IVM; Regimen 2: IVM and PQ; Regimen 3: IVM and DHA-PQP; Regimen 4: IVM and DHA-PQP and PQ;
PQ and DHA-PQP and PQDrug
Regimen 5: PQ; Regimen 7: DHA-PQP and PQ
DHA-PQPDrug
Regimen 6: DHA-PQP

Study groups in NCT02568098
Study group	Role	What they receive
TMEC-14-022 (OxTREC 39-14)	Experimental	Subjects had previously taken drug CQ and PQ Receives: Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ; Drug: PQ and DHA-PQP and PQ
TMEC 12-004 (OxTREC 58-11)	Experimental	Subjects had previously taken drug PQ and DHA-PQP Receives: Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ
New subject	Experimental	Subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)". Receives: Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ; Drug: PQ and DHA-PQP and PQ; Drug: DHA-PQP

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events
Also including abnormal clinical laboratory, vital signs and corrected QT interval (QTc) prolongation for DHA-PQP
Measured: 1.5 year

Secondary outcomes (11)

Area under the concentration-time curve AUC(0-∞)
Pharmacokinetic parameters
Measured: 1.5 year
Area under the concentration-time curve AUC(0-last)
Pharmacokinetic parameters
Measured: 1.5 year
Maximal concentration (Cmax)
Pharmacokinetic parameters
Measured: 1.5 year
Elimination clearance (CL/F)
Pharmacokinetic parameters
Measured: 1.5 year
Terminal elimination half-life (t1/2)
Pharmacokinetic parameters
Measured: 1.5 year
Apparent volume of distribution (Vd) for PQ, DHA-PQP, IVM, ABZ.
Pharmacokinetic parameters
Measured: 1.5 year
Pharmacogenetic polymorphisms in case of abnormal drug level
Pharmacogenetic polymorphisms in the case of unusually high or low drug levels.
Measured: 1.5 year
Pharmacokinetic differences of AUC(0-∞) for IVM between venous and capillary blood
Pharmacokinetic differences (AUC(0-∞)) for IVM in venous and capillary blood when given alone or together with DHA-PQP.
Measured: 1.5 year
Pharmacokinetic differences of AUC(0-last) between venous and capillary blood
Pharmacokinetic differences (AUC(0-last)) for IVM in venous and capillary blood when given alone or together with DHA-PQP.
Measured: 1.5 year
Pharmacokinetic differences of Cmax between venous and capillary blood
Pharmacokinetic differences (Cmax) for IVM in venous and capillary blood when given alone or together with DHA-PQP.
Measured: 1.5 year
Mosquito survivorship
Duration of survived mosquito post drug drug administration
Measured: 1.5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2016

First posted5 Oct 2015 (estimated)
Study startOct 2015
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug CombinationStudies of the same condition, open and under way.
More trials run by University of OxfordThe 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
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568098
Sponsor's protocol ID: FTM1501
Status last verified: May 2017
First submitted: 26 May 2015
Last updated: 31 May 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Study to Evaluate Safety, Tolerability, Potential Pharmacokinetic Interactions and Mosquito-Lethal Effects of Orally Administered Ivermectin, Primaquine, Dihydroartemisinin-Piperaquine, and Albendazole in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02568098
Acronym / sponsor ID: FTM1501
Conditions: Drug Combination, Pharmacokinetics, Healthy
Keywords: Drug combination, Ivermectin, Primaquine, Dihydroartemisinin-Piperaquine, Albendazole, Pharmacokinetics, Mosquito-Lethal Effect, Healthy adult subject
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: Mahidol University, Mahidol Oxford Tropical Medicine Research Unit
Study start: Oct 2015
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 5 Oct 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.

Primary Objective

To evaluate the safety and tolerability of co-administered single dose Dihydroartemisinin-Piperaquine (DHA-PQP), Ivermectin (IVM), Primaquine (PQ), and Albendazole (ABZ) in healthy subjects.

Secondary Objectives

To characterize the potential pharmacokinetic interactions between DHA-PQP, IVM, PQ, and ABZ in healthy adult subjects.
To characterize the pharmacokinetic properties of PQ (and its major metabolite), DHA-PQP, IVM, and ABZ (and its major metabolite) when given alone and in combination.
To investigate pharmacogenetic polymorphisms affecting drug levels of PQ, DHA-PQP, IVM, ABZ and their metabolites.
To determine mosquito lethal efficacy of IVM, PQ, ABZ, and DHA-PQP combinations against Anopheles dirus and Anopheles minimus.
To determine if IVM concentrations in venous blood differs from capillary blood.

Detailed description

This is an open-label, sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects. These 16 subjects have previously participated in either study:

Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered Primaquine (PQ) and Dihydroartemisinin-Piperaquine (DHA-PQP) in Healthy Adult Subjects (TMEC 12-004 (OxTREC ref. 58-11)) or study
Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine (CQ) and piperaquine (PQ) in healthy Thai subjects (TMEC 14-022 (OxTREC ref. 39-14)) or
subjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)".

Subjects will be admitted in the inpatient ward to receive single dose of 6 regimens (regimens 1-4 and 8-9) described below. Every subject will have at least 6 admissions in the hospital.

The subjects from TMEC-14-022 (OxTREC ref. 39-14) will have two additional admissions to receive two additional regimen PQ, and DHA-PQP with PQ

**w-o = washout period

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TMEC-14-022 (OxTREC 39-14)	Experimental	Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ, Drug: PQ and DHA-PQP and PQSubjects had previously taken drug CQ and PQ
TMEC 12-004 (OxTREC 58-11)	Experimental	Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQSubjects had previously taken drug PQ and DHA-PQP
New subject	Experimental	Drug: IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ, Drug: PQ and DHA-PQP and PQ, Drug: DHA-PQPSubjects who not previously participated in study "TMEC 12-004 (OxTREC ref. 58-11)" and study "TMEC 14-022 (OxTREC ref. 39-14)".

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
Males and Females non-smoker aged between 18 years to 60 years.
Males and Females weight between 36-75 kilograms.
A female is eligible to enter and participate in this study if she is:
A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.

Key exclusion criteria (21 listed)

Females who are pregnant, trying to get pregnant, or are lactating.
The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia) or with a family history of sudden cardiac death.
A creatinine clearance (CLcr) <70 mL/min as determined by Cockcroft-Gault equation:

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
IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQRegimen 1: IVM; Regimen 2: IVM and PQ; Regimen 3: IVM and DHA-PQP; Regimen 4: IVM and DHA-PQP and PQ;	Drug	New subject, TMEC 12-004 (OxTREC 58-11), TMEC-14-022 (OxTREC 39-14)
PQ and DHA-PQP and PQRegimen 5: PQ; Regimen 7: DHA-PQP and PQ	Drug	New subject, TMEC-14-022 (OxTREC 39-14)
DHA-PQPRegimen 6: DHA-PQP	Drug	New subject

Primary outcome

Number of Participants with Adverse Events
Time frame: 1.5 year
Also including abnormal clinical laboratory, vital signs and corrected QT interval (QTc) prolongation for DHA-PQP

11 secondary outcomes

Area under the concentration-time curve AUC(0-∞)
Time frame: 1.5 year
Area under the concentration-time curve AUC(0-last)
Time frame: 1.5 year
Maximal concentration (Cmax)
Time frame: 1.5 year
Elimination clearance (CL/F)
Time frame: 1.5 year
Terminal elimination half-life (t1/2)
Time frame: 1.5 year
Apparent volume of distribution (Vd) for PQ, DHA-PQP, IVM, ABZ.
Time frame: 1.5 year
Pharmacogenetic polymorphisms in case of abnormal drug level
Time frame: 1.5 year
Pharmacokinetic differences of AUC(0-∞) for IVM between venous and capillary blood
Time frame: 1.5 year
Pharmacokinetic differences of AUC(0-last) between venous and capillary blood
Time frame: 1.5 year
Pharmacokinetic differences of Cmax between venous and capillary blood
Time frame: 1.5 year
Mosquito survivorship
Time frame: 1.5 year

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 31 May 2017.

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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.

Dr.Podjanee Jittamala, MD principal investigator

Mahidol University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 21 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 31 May 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 Thailand. 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 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.

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?

Number of Participants with Adverse Events (time frame: 1.5 year). 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 NCT02568098.

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 31 May 2017.