Heart FailurePhase 1/2NCT01092325
Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure
A Phase 1/2 study testing CXL-1020, CXL-1020 Dose for Echo Cohort A and CXL-1020 Doses for Echo Cohort B in people with Heart Failure, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CXL-1020, CXL-1020 Dose for Echo Cohort A and CXL-1020 Doses for Echo Cohort B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for randomization, a patient MUST:
- Be a male or post menopausal or surgically sterile female outpatient between 18 and 85 years of age
- Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension, and stable for at least 30 days prior to screening
- Have a core echo lab confirmed left ventricular ejection fraction ≤ 40% in a baseline 2D-Echocardiogram prior to and within 60 days of the first dose of study medication with evidence of at least minimal LV dilation on the basis of an observed LV-EDV index that is above normal
- Have a baseline NT-Pro-BNP of greater than or equal to the top of the normal reference range (124pg/ml) prior to and within 60 days of the first dose of study medication
- Be on unchanging doses of HF medications (with exception of diuretic dosage) for 2 weeks prior to randomization without planned initiation of new hemodynamically active therapy during the conduct of the study
Show all 11Show fewer
- Be capable of understanding the nature of the trial and be willing to participate as documented by written informed consent
- Be willing and able to comply with the study protocol requirements for the duration of the study, including pharmacokinetic sampling
- If a post-menopausal or surgically sterile female, confirmation of sterility status (Post menopausal or surgically sterile for at least 6 months) - (Post-menopausal subjects will require a urine pregnancy test for confirmation prior to enrollment and urine pregnancy tests prior to each dosing)
- If a fertile male, must be using 2 approved contraceptive methods (a condom and a spermicidal agent, even if the partner is using birth control) for the duration of the study and for 3 months following participation in the study and further agree to not donate sperm for 3 months after participation in the study. Must have a negative urine test for drugs of abuse and a negative ethanol breath test at screening and before each dosing period
- Have required local lab data within non-exclusionary ranges before each dosing
Who cannot join
- In order to be eligible for randomization, a patient MUST NOT:
- Have participated in any investigational drug study within 30 days preceding randomization or have previously received therapy with CXL-1020
- Have a heart rate <50 or ≥ 90 BPM at baseline prior to randomization.
- Have a blood pressure >150 Systolic and/or >90 diastolic mmHg at baseline prior to randomization
- Have a systolic blood pressure of less than 100 mmHg at baseline prior to randomization
- Have QT/QTc prolongation > 460 msec or > 500msec in patients with preexisting bundle branch block (only applies to non-paced patients in sinus rhythm)
Show all 31Show fewer
- Have experienced a documented symptomatic or electrocardiographically recorded episode of atrial fibrillation/flutter within 60 days before screening and be in normal sinus rhythm at each baseline before study drug is administered
- Have a history of sustained or hemodynamically significant VT or VF requiring cardioversion, or self-terminating VT associated with hypotension
- Have non-sustained VT (HR > 120 bpm) of 10 beats or more during monitoring in the baseline monitoring period prior to each dose of study medication, or in any Holter or EKG recording within 1 year of first dose of study medication.
- Have a weight or height that exceeds the specifications for the ICG Device of (greater than 341 pounds or taller than 7 feet 2 inches.)
- Be post-successful cardiac resuscitation
- Have a history of worsening HF within 30 days prior to screening as defined by:
- Unscheduled ER or clinic visits relating to HF or hospital admission for management of HF
- Treatment with intravenous inotropic or vasodilator drugs
- Be diagnosed with acute coronary syndrome or acute myocardial infarction within three months prior to screening
- Have a history of stroke (CVA) or transient ischemic attack (TIA) within six months prior to screening
- Have a history of CCS Class III or IV angina
- Be a patient whose HF etiology is attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness > 1.8 cm) or uncorrected severe valvular disease
- Be receiving concomitant therapy with any antiarrhythmic drugs other than amiodarone
- Have experienced the firing of an implantable ICD for documented ventricular ectopy within three months prior to screening
- Have a known allergy to the ICG Device sensor gel or adhesive
- Have unsuitable Echocardiographic Windows for the comprehensive Echo assessments required in the Echo cohorts (exclusion for echo cohorts only)
- Have a skin lesion at the site of the ICG Device sensor placement.
- Have a screening or baseline serum Na < 130 mEq/l or > 145 mEq/l; a serum K < 3.5 mEq/l or > 5.0 mEq/l; a serum Ca < 7.5 mg/dl or > 10 mg/dl; or a serum Mg < 1.6 mEq/l or > 3.0 mEq/l., or a digoxin level above 1ng/ml
- Have a screening TSH < 0.1 mcU/ml or > 5.0 mcU/ml
- Have a screening or baseline serum creatinine > 2.5 mg/dl; an ALT or AST >3 times the upper normal limit; or a hemoglobin < 10 g/dl
- Have taken ethanol within 24 hours or a PDE5 inhibitor within 96 hours of study admission
- Have other clinically significant laboratory or medical conditions that, in the opinion of the Investigator, make the patient unsuitable for evaluation in the study
- Have a generalized atopic state or a history of a mild to moderate documented drug allergy
- Be receiving a drug which is expected to possess the potential for a clinically significant pharmacokinetic interaction with CXL-1020, as defined in the IDB.
- Note: Patients receiving cardiac resynchronization therapy for HF are eligible provided that the device has been placed for greater than 30 days and pacemaker settings can be left unchanged for the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Clinical Research Center
Tustin, California, 92780
About this study
Official title: A Phase I/IIa Dose-Escalation Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients With Chronic Heart Failure
A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure
Read the detailed description
This is a Phase I/IIa Dose-Escalation, First exposure in Humans, Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients with Chronic Heart Failure. 4 weekly four-hour treatments involving ascending dosages of CXL-1020 with a randomly interspersed placebo dose within two or more unique patient cohorts. Separate echocardiography cohorts (Echo Cohort A and Echo Cohort B) will evaluate a sustained dose over 4 hours (ECHO A), and an ascending two dose level, 4-hour infusion (2 hours each) (ECHO B), in individual patients. Echo Cohort dosages will be determined from responses observed in previous cohort exposures.
- Conditions
- Heart Failure
- Being tested
- CXL-1020, Placebo for CXL-1020 Cohort 1, Placebo for CXL-1020 Cohort 2, CXL-1020 Dose for Echo Cohort A, CXL-1020 Doses for Echo Cohort B
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXL-1020Drug
Intravenous infusion of one of 3 active dosages of CXL-1020
CXL-1020Drug
Intravenous infusion of one of 3 active dosages of CXL-1020 at dosages higher than in Cohort 1
Placebo for CXL-1020 Cohort 1Drug
A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)
Placebo for CXL-1020 Cohort 2Drug
A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)
CXL-1020 Dose for Echo Cohort ADrug
A 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect
CXL-1020 Doses for Echo Cohort BDrug
A 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 CXL-1020 | Experimental | An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. Receives: Drug: CXL-1020 |
| Cohort 1 Placebo | Placebo comparator | A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 Receives: Drug: Placebo for CXL-1020 Cohort 1 |
| Cohort 2 CXL-1020 | Experimental | An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. Receives: Drug: CXL-1020 |
| Cohort 2 Placebo | Placebo comparator | A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 Receives: Drug: Placebo for CXL-1020 Cohort 2 |
| Echo Cohort A CXL-1020 | Active comparator | A 4 hour infusion of a fixed dose of CXL-1020 which was studied in Cohort 1 or Cohort 2 which is expected to be well tolerated and have hemodynamic effect Receives: Drug: CXL-1020 Dose for Echo Cohort A |
| Echo Cohort B CXL-1020 | Active comparator | CXL-1020 administered at a fixed rate for the initial 2 hours and at a higher fixed rate for the last 2 hours of a 4 hour infusion at doses which were studied in Cohort 1 or Cohort 2 and expected to be well tolerated and have hemodynamic effects Receives: Drug: CXL-1020 Doses for Echo Cohort B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Safety is measured by assessment of multiple parameters including standard laboratory safety, changes in blood pressure and heart rate, changes in electrocardiogram, monitoring of heart rhythm via holter monitor, measurement of cardiac safety biomarkers such as plasma troponin as well as treatment emergent adverse events
Measured: From initial exposure to 30 days following exposure
Secondary outcomes (2)
Hemodynamic Effects as Measured by Impedance Cardiography and Echocardiography
Standard measurement of impedance cardiography parameters will be made non invasively in all study cohorts. Echocardiography will be evaluated in parallel with Impedance cardiography in the Echo Cohorts
Measured: before during and following the infusion of study medication
Plasma and Urinary Pharmacokinetics
Measurement of plasma samples and urine collections for CXL-1020 and metabolites. Samples are collected approximately 19 times from a intravenous catheter, before during and following infusion. In addition 4 collections of all freely voided urine will be collected from before infusion until 18 hours following infusion.
Measured: From start of infusion until 18 hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cardioxyl Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Doug Cowart, Pharm D., Study director, Cardioxyl Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092325
- Sponsor's protocol ID
- CXL-1020-01
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2010
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
A Phase I/IIa First in Man Safety and Tolerability Study of a Novel HNO Donor, CXL-1020, in Patients with Stable Congestive Heart Failure. Monday, April 4, 2011; 9:30 a.m. - 12:30 p.m., Ernest N. Morial Convention Center, Hall F; Poster Board #42
Sabbah HN, Tocchetti CG, Wang M, Daya S, Gupta RC, Tunin RS, Mazhari R, Takimoto E, Paolocci N, Cowart D, Colucci WS, Kass DA. Nitroxyl (HNO): A novel approach for the acute treatment of heart failure. Circ Heart Fail. 2013 Nov;6(6):1250-8. doi: 10.1161/CIRCHEARTFAILURE.113.000632. Epub 2013 Oct 9.
PubMed 24107588
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Dose-Escalation Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01092325
- Acronym / sponsor ID
- CXL-1020-01
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Cardioxyl Pharmaceuticals, Inc
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Mar 2010 (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.
A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure
Detailed description
This is a Phase I/IIa Dose-Escalation, First exposure in Humans, Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients with Chronic Heart Failure. 4 weekly four-hour treatments involving ascending dosages of CXL-1020 with a randomly interspersed placebo dose within two or more unique patient cohorts. Separate echocardiography cohorts (Echo Cohort A and Echo Cohort B) will evaluate a sustained dose over 4 hours (ECHO A), and an ascending two dose level, 4-hour infusion (2 hours each) (ECHO B), in individual patients. Echo Cohort dosages will be determined from responses observed in previous cohort exposures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 CXL-1020 | Experimental | Drug: CXL-1020An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. |
| Cohort 1 Placebo | Placebo comparator | Drug: Placebo for CXL-1020 Cohort 1A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 |
| Cohort 2 CXL-1020 | Experimental | Drug: CXL-1020An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. |
| Cohort 2 Placebo | Placebo comparator | Drug: Placebo for CXL-1020 Cohort 2A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 |
| Echo Cohort A CXL-1020 | Active comparator | Drug: CXL-1020 Dose for Echo Cohort AA 4 hour infusion of a fixed dose of CXL-1020 which was studied in Cohort 1 or Cohort 2 which is expected to be well tolerated and have hemodynamic effect |
| Echo Cohort B CXL-1020 | Active comparator | Drug: CXL-1020 Doses for Echo Cohort BCXL-1020 administered at a fixed rate for the initial 2 hours and at a higher fixed rate for the last 2 hours of a 4 hour infusion at doses which were studied in Cohort 1 or Cohort 2 and expected to be well tolerated and have hemodynamic effects |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be a male or post menopausal or surgically sterile female outpatient between 18 and 85 years of age
- Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension, and stable for at least 30 days prior to screening
- Have a core echo lab confirmed left ventricular ejection fraction ≤ 40% in a baseline 2D-Echocardiogram prior to and within 60 days of the first dose of study medication with evidence of at least minimal LV dilation on the basis of an observed LV-EDV index that is above normal
- Have a baseline NT-Pro-BNP of greater than or equal to the top of the normal reference range (124pg/ml) prior to and within 60 days of the first dose of study medication
- Be on unchanging doses of HF medications (with exception of diuretic dosage) for 2 weeks prior to randomization without planned initiation of new hemodynamically active therapy during the conduct of the study
Key exclusion criteria (31 listed)
- Have participated in any investigational drug study within 30 days preceding randomization or have previously received therapy with CXL-1020
- Have a heart rate <50 or ≥ 90 BPM at baseline prior to randomization.
- Have a blood pressure >150 Systolic and/or >90 diastolic mmHg at baseline prior to randomization
- Have a systolic blood pressure of less than 100 mmHg at baseline prior to randomization
- Have QT/QTc prolongation > 460 msec or > 500msec in patients with preexisting bundle branch block (only applies to non-paced patients in sinus rhythm)
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 |
|---|---|---|
| CXL-1020Intravenous infusion of one of 3 active dosages of CXL-1020 | Drug | Cohort 1 CXL-1020 |
| CXL-1020Intravenous infusion of one of 3 active dosages of CXL-1020 at dosages higher than in Cohort 1 | Drug | Cohort 2 CXL-1020 |
| Placebo for CXL-1020 Cohort 1A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water) | Drug | Cohort 1 Placebo |
| Placebo for CXL-1020 Cohort 2A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water) | Drug | Cohort 2 Placebo |
| CXL-1020 Dose for Echo Cohort AA 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect | Drug | Echo Cohort A CXL-1020 |
| CXL-1020 Doses for Echo Cohort BA 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect | Drug | Echo Cohort B CXL-1020 |
Primary outcome
Safety and Tolerability
Time frame: From initial exposure to 30 days following exposure
Safety is measured by assessment of multiple parameters including standard laboratory safety, changes in blood pressure and heart rate, changes in electrocardiogram, monitoring of heart rhythm via holter monitor, measurement of cardiac safety biomarkers such as plasma troponin as well as treatment emergent adverse events
2 secondary outcomes
Hemodynamic Effects as Measured by Impedance Cardiography and Echocardiography
Time frame: before during and following the infusion of study medication
Plasma and Urinary Pharmacokinetics
Time frame: From start of infusion until 18 hours post infusion
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 1 Jul 2016.
- Results publicationA Phase I/IIa First in Man Safety and Tolerability Study of a Novel HNO Donor, CXL-1020, in Patients with Stable Congestive Heart Failure. Monday, April 4, 2011; 9:30 a.m. - 12:30 p.m., Ernest N. Morial Convention Center, Hall F; Poster Board #42
- Derived from this study: PubMed 24107588Sabbah HN, Tocchetti CG, Wang M, Daya S, Gupta RC, Tunin RS, Mazhari R, Takimoto E, Paolocci N, Cowart D, Colucci WS, Kass DA. Nitroxyl (HNO): A novel approach for the acute treatment of heart failure. Circ Heart Fail. 2013 Nov;6(6):1250-8. doi: 10.1161/CIRCHEARTFAILURE.113.000632. Epub 2013 Oct 9.
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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.
Doug Cowart, Pharm D. study director
Cardioxyl Pharmaceuticals
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 CXL-1020, CXL-1020 Dose for Echo Cohort A and CXL-1020 Doses for Echo Cohort B in people with Heart Failure, run by Bristol-Myers Squibb at 1 site in United States.
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 31 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 1 Jul 2016. 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 United States. 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 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?
Safety and Tolerability (time frame: From initial exposure to 30 days following exposure). 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 NCT01092325, 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 1 Jul 2016.