AsthmaPhase 1NCT02882217

Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8

A Phase 1 study testing XC8 (histamine glutarimide) in people with Asthma, run by EURRUS Biotech GmbH at 2 sites in 2 countries.

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

The study focusses on the evaluation of safety and tolerability of the XC8. The design of the study involves sequential dosing of cohorts (group of volunteers), taking increasing doses of the product after receiving conclusion and recommendation for further continuation of the study from the Dose Escalation Committee. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: XC8 (histamine glutarimide)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2016to May 2017
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women aged 18 to 50 years;
Generally good health;
Body mass index of 19 to 30 kg/m² and >50 kg body weight;
Female subjects who are post-menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practice a highly effective method of birth control, i.e. resulting in a failure rate of less than 1% per year when used consistently and correctly (e.g. implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence, or vasectomized partner). The birth control method must have been applied for at least 1 cycle before and until 3 months after administration of the study medication.
Male subjects with a female partner of child-bearing potential agree to use a medically acceptable method of contraception (e.g. condoms, sexual abstinence, vasectomy) during the study, and until 3 months after the last intake of study medication.
Subjects are willing and able (in the opinion of the investigator) to understand and comply with the procedures and evaluations of the study.
Subjects must be willing and legally able to give written informed consent.

Who cannot join

Hepatic or renal disease; any other disease, which may influence the clinical trial results or may lead to health worsening during the trial (according to the investigator's opinion);
Clinically significant laboratory abnormalities;
Use of any medication, including prophylaxis, within 1 month before screening (including herbal preparations and nutritional supplements);
Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus HBV at Screening;
Irregular sleep (e.g. night work, sleep disturbances, insomnia, returning from another time zone, etc.);
History or current evidence of alcohol or drug abuse; alcohol or drug intake within 4 days before Screening;

Show all 17Show fewer

History or current evidence of allergic reactions (including reactions to medications and food);
History or current evidence of symptomatic rhinitis within 2 years before Screening (allergic rhinitis, non-allergic rhinitis, or hay fever, excluding short-term viral infection - cold or influenza);
Blood or plasma donation, or surgery (in hospital) within 12 weeks of Screening;
Lactating or pregnant females; a positive pregnancy test before the first administration of investigational medicinal product or breastfeeding;
Current or previous (within 3 months of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study;
Previous enrollment in this clinical study;
Inability to understand or follow protocol instructions;
Smoking within 3 months before screening or throughout the study;
Lactose intolerance;
History of allergic reactions to XC-8 or any inactive ingredients of the trial medication;
Employees of the sponsor or subjects who are employees or relatives of the investigator;

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Austria1 site

Karl Landsteiner Institut für experimentelle und klinische Pneumologie, Wolkersbergenstraße 1
Vienna, 1130

Other trials in Austria

Germany1 site

Fraunhofer Institut für Toxikologie und Experimentelle Medizin ITEM, Feodor-Lynen-Str.15
Hanover, 30625

Other trials in Germany

About this study

Official title: Double-blind, Randomized, Dose-escalating, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8 After Single and Multiple Oral Doses in Healthy Volunteers

Conditions: Asthma
Being tested: XC8 (histamine glutarimide), Placebo
Keywords: Double-blind, Randomized, Dose-escalating, Placebo-controlled, Phase I, Healthy volunteers, Bronchial asthma, Histamine glutarimide, EURRUS
Medical subject headings: Asthma

What participants receive

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

XC8 (histamine glutarimide)Drug
PlaceboDrug

Study groups in NCT02882217
Study group	Role	What they receive
XC8 10mg	Active comparator	Cohort 1: 8 subjects will be randomized in a 3:1 ratio to be treated either with 10mg XC8 (6 subjects) or placebo (2 subjects, see placebo arm) Receives: Drug: XC8 (histamine glutarimide)
XC8 50mg	Active comparator	Cohort 2: 8 subjects will be randomized in a 3:1 ratio to be treated either with 50mg XC8 (6 subjects) or placebo (2 subjects, see placebo arm) Receives: Drug: XC8 (histamine glutarimide)
XC8 200mg	Active comparator	Cohort 3: 16 subjects will be randomized in a 3:1 ratio to be treated either with 200mg XC8 (12 subjects) or placebo (4 subjects, see placebo arm) Receives: Drug: XC8 (histamine glutarimide)
Placebo	Placebo comparator	Placebo comparator arm consists of 2 subjects in the cohorts 1 and 2 each and 4 subjects in the cohort 3. Receives: Drug: Placebo

What is being measured

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

Number of Adverse events per treatment arm
Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects
Measured: Change from pre-dose up to Day 36
Laboratory data
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Measured: Changes from Day 1 (pre-dose) till Day 2
Laboratory data
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Measured: Changes from Day 8 (pre-dose) till Day 10
Laboratory data
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Measured: Changes from Day 8 (pre-dose) till Day 15
Physical examination
Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system.
Measured: Day 1
Physical examination
Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system.
Measured: Day 8
12-lead ECG
12-lead ECG results will be analyzed descriptively
Measured: Change from pre-dose till Day 2
12-lead ECG
12-lead ECG results will be analyzed descriptively
Measured: Day 8
Vital signs
Vital signs (blood pressure, respiratory rate, pulse, and temperature) results will be analyzed descriptively.
Measured: Changes from pre-dose till Day 36

Secondary outcomes (10)

Pharmacokinetics of XC8 by assessing AUCinf
Area under the plasma concentration-time curve extrapolated to infinity
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Cmax
Maximum plasma concentration
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing AUC0-tlast
Area under the plasma concentration-time curve up to the last sampling time with a concentration above the limit of quantification
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing AUC0-24
Area under the plasma concentration-time curve up to 24 hours after study drug administration
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing t1/2
Terminal elimination half-life
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Tmax
Time to reach Cmax
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing λz
Apparent first order terminal elimination rate constant
Measured: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Cav
Average concentration over one dosing interval
Measured: Day 8 to 11, 13 and 15 (Pre dose); Day 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 22 (24 hours ±10 minutes post dose)
Pharmacodynamic analyses: blood eosinophils
Measured: changes from Day 1 (pre-dose) to Day 2 and Day 8 (pre-dose) to Day 22
Pharmacodynamic analyses: blood cytokines
Measured: changes from Day 1 (pre-dose) to Day 2 and Day 8 (pre-dose) to Day 22

Timeline

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

Aug 2016May 2017

First posted29 Aug 2016 (estimated)
Study startAug 2016
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02882217
Sponsor's protocol ID: PULM-XC8-03
Status last verified: May 2017
First submitted: 1 Aug 2016
Last updated: 18 May 2017
Results posted: No
Data monitoring committee: No

Publications

Renner A, Romanova J, Ferko B, Schmutz H, Nebolsin V, Muller M, Badorrek P, Marth K, Pohl W. Safety, pharmacokinetics and pharmacodynamics of a novel anti-asthmatic drug, XC8, in healthy probands. Pulm Pharmacol Ther. 2019 Dec;59:101852. doi: 10.1016/j.pupt.2019.101852. Epub 2019 Oct 6.
PubMed 31597083

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomized, Dose-escalating, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8 After Single and Multiple Oral Doses in Healthy Volunteers
ClinicalTrials.gov ID: NCT02882217
Acronym / sponsor ID: PULM-XC8-03
Conditions: Asthma
Keywords: Double-blind, Randomized, Dose-escalating, Placebo-controlled, Phase I, Healthy volunteers, Bronchial asthma, Histamine glutarimide
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: EURRUS Biotech GmbHIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 29 Aug 2016 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
XC8 10mg	Active comparator	Drug: XC8 (histamine glutarimide)Cohort 1: 8 subjects will be randomized in a 3:1 ratio to be treated either with 10mg XC8 (6 subjects) or placebo (2 subjects, see placebo arm)
XC8 50mg	Active comparator	Drug: XC8 (histamine glutarimide)Cohort 2: 8 subjects will be randomized in a 3:1 ratio to be treated either with 50mg XC8 (6 subjects) or placebo (2 subjects, see placebo arm)
XC8 200mg	Active comparator	Drug: XC8 (histamine glutarimide)Cohort 3: 16 subjects will be randomized in a 3:1 ratio to be treated either with 200mg XC8 (12 subjects) or placebo (4 subjects, see placebo arm)
Placebo	Placebo comparator	Drug: PlaceboPlacebo comparator arm consists of 2 subjects in the cohorts 1 and 2 each and 4 subjects in the cohort 3.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Men and women aged 18 to 50 years;
Generally good health;
Body mass index of 19 to 30 kg/m² and >50 kg body weight;
Female subjects who are post-menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practice a highly effective method of birth control, i.e. resulting in a failure rate of less than 1% per year when used consistently and correctly (e.g. implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence, or vasectomized partner). The birth control method must have been applied for at least 1 cycle before and until 3 months after administration of the study medication.
Male subjects with a female partner of child-bearing potential agree to use a medically acceptable method of contraception (e.g. condoms, sexual abstinence, vasectomy) during the study, and until 3 months after the last intake of study medication.

Key exclusion criteria (17 listed)

Hepatic or renal disease; any other disease, which may influence the clinical trial results or may lead to health worsening during the trial (according to the investigator's opinion);
Clinically significant laboratory abnormalities;
Use of any medication, including prophylaxis, within 1 month before screening (including herbal preparations and nutritional supplements);
Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus HBV at Screening;
Irregular sleep (e.g. night work, sleep disturbances, insomnia, returning from another time zone, etc.);

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
XC8 (histamine glutarimide)	Drug	XC8 10mg, XC8 200mg, XC8 50mg
Placebo	Drug	Placebo

Primary outcome

Number of Adverse events per treatment arm
Time frame: Change from pre-dose up to Day 36
Adverse events will be summarized descriptively by treatment arm. Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version. For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects
Laboratory data
Time frame: Changes from Day 1 (pre-dose) till Day 2
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Laboratory data
Time frame: Changes from Day 8 (pre-dose) till Day 10
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Laboratory data
Time frame: Changes from Day 8 (pre-dose) till Day 15
Laboratory data (hematology, biochemistry and urinalysis) will be summarized by treatment arm. Changes from pre-dose will be presented using shift tables (employing the categories 'normal', 'abnormal, clinically not significant' and 'abnormal, clinically significant') and absolute changes in laboratory values, if appropriate.
Physical examination
Time frame: Day 1
Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system.
Physical examination
Time frame: Day 8
Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system.
12-lead ECG
Time frame: Change from pre-dose till Day 2
12-lead ECG results will be analyzed descriptively
12-lead ECG
Time frame: Day 8
12-lead ECG results will be analyzed descriptively
Vital signs
Time frame: Changes from pre-dose till Day 36
Vital signs (blood pressure, respiratory rate, pulse, and temperature) results will be analyzed descriptively.

10 secondary outcomes

Pharmacokinetics of XC8 by assessing AUCinf
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Cmax
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing AUC0-tlast
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing AUC0-24
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing t1/2
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Tmax
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing λz
Time frame: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose); Day 8 to 11, 13 and 15 (Pre dose)
Pharmacokinetics of XC8 by assessing Cav
Time frame: Day 8 to 11, 13 and 15 (Pre dose); Day 21 (Pre dose, and 20 min, 40 min, 1, 2, 4 and 8 hours post dose), Day 22 (24 hours ±10 minutes post dose)
Pharmacodynamic analyses: blood eosinophils
Time frame: changes from Day 1 (pre-dose) to Day 2 and Day 8 (pre-dose) to Day 22
Pharmacodynamic analyses: blood cytokines
Time frame: changes from Day 1 (pre-dose) to Day 2 and Day 8 (pre-dose) to Day 22

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 18 May 2017.
Derived from this study: PubMed 31597083Renner A, Romanova J, Ferko B, Schmutz H, Nebolsin V, Muller M, Badorrek P, Marth K, Pohl W. Safety, pharmacokinetics and pharmacodynamics of a novel anti-asthmatic drug, XC8, in healthy probands. Pulm Pharmacol Ther. 2019 Dec;59:101852. doi: 10.1016/j.pupt.2019.101852. Epub 2019 Oct 6.

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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.

Helmut Schmutz, Mag.iur. study director

EURRUS Biotech GmbH

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XC8 (histamine glutarimide) in people with Asthma, run by EURRUS Biotech GmbH at 2 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 7 inclusion and 17 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 18 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 2 sites in Austria, Germany. 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. Some participants in this study may receive a placebo. 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 Adverse events per treatment arm (time frame: Change from pre-dose up to Day 36). The study lists 9 primary outcomes in all. 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 NCT02882217, which also lists 1 linked publication.

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 18 May 2017.