Immune Thrombocytopenic PurpuraPhase 1/2ITPNCT02273960

Study to Evaluate Safety and Efficacy in Adult Subjects With ITP

A Phase 1/2 study testing BMS-986004 75 mg IV, BMS-986004 225 mg IV and BMS-986004 675 mg IV in people with Immune Thrombocytopenic Purpura, run by Bristol-Myers Squibb at 20 sites in 8 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 purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immune Thrombocytopenic Purpura
What is being tested?: BMS-986004 75 mg IV, BMS-986004 225 mg IV and BMS-986004 675 mg IV
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 20 sitesin 8 countries
Study dates: 17 Nov 2014to 22 Jan 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥18 years old, diagnosed with persistent or chronic ITP

Who cannot join

Secondary immune thrombocytopenia
Drug induced thrombocytopenia

Trial locations and contacts

20 sites in 8 countries.

Country

City, postcode or hospital

20 sites in 8 countries

United States6 sites

Emory University
Atlanta, Georgia, 30322
Mass General Hospital
Boston, Massachusetts, 02114
Columbus Regional Research Institute
Columbus, Georgia, 31904
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Rutgers- Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom4 sites

Local Institution
Glasgow, Lanarkshire, G4 OSF
Local Institution
London, Greater London, NW1 2PG
Local Institution
London, E1 1BB
Local Institution
Manchester, Greater Manchester, M13 9WL

Other trials in United Kingdom

Poland3 sites

Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
Chorzów, 41-500
Specjalistyczny Gabinet Lekarski Prof. dr hab. Krzysztof Giannopoulos
Lublin, 20-601
Local Institution
Warsaw, 02-106

Other trials in Poland

Australia2 sites

Local Institution
Brisbane, Queensland, 4102
Local Institution
Randwick, New South Wales, 2031

Other trials in Australia

Russia2 sites

Local Institution
Saint Petersburg, 194356
Local Institution
Smolensk

Other trials in Russia

Canada1 site

Hamilton Health Sciences/Mc Master Univ Med Ctre
Hamilton, Ontario, L8S 4K1

Other trials in Canada

Georgia1 site

Local Institution
Tbilisi, 0112

Other trials in Georgia

Moldova1 site

Local Institution
Chisinau, MD 2025

Other trials in Moldova

About this study

Official title: Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)

The purpose of this study is to assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.

Conditions: Immune Thrombocytopenic Purpura
Being tested: BMS-986004 75 mg IV, BMS-986004 225 mg IV, BMS-986004 675 mg IV, BMS-986004 1500 mg IV
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic

What participants receive

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

BMS-986004 75 mg IVDrug
BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
BMS-986004 225 mg IVDrug
BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
BMS-986004 675 mg IVDrug
BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
BMS-986004 1500 mg IVDrug
BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes

Study groups in NCT02273960
Study group	Role	What they receive
Arm A: BMS-986004	Experimental	BMS-986004 solution intravenously (IV) as specified Receives: Drug: BMS-986004 75 mg IV
Arm B: BMS-986004	Experimental	BMS-986004 solution intravenously as specified Receives: Drug: BMS-986004 225 mg IV
Arm C: BMS-986004	Experimental	BMS-986004 solution intravenously as specified Receives: Drug: BMS-986004 675 mg IV
Arm D: BMS-986004	Experimental	BMS-986004 solution intravenously as specified Receives: Drug: BMS-986004 1500 mg IV

What is being measured

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

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
Measured: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Number of ECG Abnormalities
The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
Measured: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml.
Measured: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)

Secondary outcomes (6)

Response Rate (RR) of BMS-986004: Short Term and Long Term
Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding.
Measured: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Maximum Observed Serum Concentration (Cmax) of BMS-986004
Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Measured: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Measured: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Trough Observed Serum Concentration (Ctrough) of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Measured: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Total Body Clearance (CLT) of BMS-986004
Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Measured: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
AUC Accumulation Index (AI_AUC) of BMS-986004
AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.
Measured: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)

Timeline

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

17 Nov 201422 Jan 2018

First posted24 Oct 2014 (estimated)
Study start17 Nov 2014
Primary completion22 Jan 2018
Study completion22 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immune Thrombocytopenic PurpuraStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02273960
Sponsor's protocol ID: IM140-103
Other IDs: 2014-001429-33, 2014
Acronym: ITP
Status last verified: Jul 2019
First submitted: 3 Oct 2014
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: 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?

See locations

RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia

All Immune Thrombocytopenic Purpura trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT02273960
Acronym / sponsor ID: ITP / IM140-103
Conditions: Immune Thrombocytopenic Purpura
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 17 Nov 2014 (actual)
Primary completion: 22 Jan 2018 (actual)
Study completion: 22 Jan 2018 (actual)
First posted: 24 Oct 2014 (estimated)
Results: Posted 1 Apr 2019

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 assess the safety and tolerability of BMS-986004 when administered in subjects with ITP.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm A: BMS-986004	Experimental	Drug: BMS-986004 75 mg IVBMS-986004 solution intravenously (IV) as specified
Arm B: BMS-986004	Experimental	Drug: BMS-986004 225 mg IVBMS-986004 solution intravenously as specified
Arm C: BMS-986004	Experimental	Drug: BMS-986004 675 mg IVBMS-986004 solution intravenously as specified
Arm D: BMS-986004	Experimental	Drug: BMS-986004 1500 mg IVBMS-986004 solution intravenously as specified

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

≥18 years old, diagnosed with persistent or chronic ITP

Key exclusion criteria (2 listed)

Secondary immune thrombocytopenia
Drug induced thrombocytopenia

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
BMS-986004 75 mg IVBMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes	Drug	Arm A: BMS-986004
BMS-986004 225 mg IVBMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes	Drug	Arm B: BMS-986004
BMS-986004 675 mg IVBMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes	Drug	Arm C: BMS-986004
BMS-986004 1500 mg IVBMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes	Drug	Arm D: BMS-986004

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods
Number of ECG Abnormalities
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)
Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)
D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml.

6 secondary outcomes

Response Rate (RR) of BMS-986004: Short Term and Long Term
Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)
Maximum Observed Serum Concentration (Cmax) of BMS-986004
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Trough Observed Serum Concentration (Ctrough) of BMS-986004
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
Total Body Clearance (CLT) of BMS-986004
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)
AUC Accumulation Index (AI_AUC) of BMS-986004
Time frame: Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)

Results and safety

Results posted to the registry on 1 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMS-986004 75mg IV	5	0
BMS-986004 225mg IV	6	0
BMS-986004 675 mg IV	5	1
BM-986004 1500 mg IV	10	4

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term

Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term). Count of participants. Unit: Participants

Measure	BMS 75 mg n = 5	BMS 225 mg n = 6	BMS-986004 675 mg IV n = 5	BMS 1500mg n = 10
Number of participants with AEs	1	5	5	9
Number of participants with SAEs	0	0	1	1

Population analysed: All participants who had received at least 1 dose of study treatment

Primary outcome: Number of ECG Abnormalities

Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term). Number. Unit: Events

Measure	BMS 75 mg n = 5	BMS 225 mg n = 6	BMS-986004 675 mg IV n = 5	BMS 1500mg n = 10
Screening	1	3	2	3
Day 1	1	2	2	3
Day 71	0	2	0	0
Day 72	1	0	1	1
End of Treatment	1	3	2	1
LTE Day 1	0	0	0	2
LTE Day 71	0	0	0	2
End of LTE	0	0	0	1

Population analysed: All participants who had received at least 1 dose of study treatment

Primary outcome: Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)

Time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term). Number. Unit: Events

Measure	BMS 75 mg n = 5	BMS 225 mg n = 6	BMS-986004 675 mg IV n = 5	BMS 1500mg n = 10
# of events: d-Dimer, Normal	56	81	60	106
# of events: d-Dimer, High	12	14	15	17
# of events: TAT Complex, Normal	52	71	46	112
# of events: TAT Complex, High	21	30	31	28

Population analysed: All participants who had received at least 1 dose of study treatment

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All SAEs were collected that occurred during 21 day screening period, a 12 week treatment period (6 weeks of response Phase and 6 weeks of remission phase) and a 1 month follow up period. The collection of nonserious AE information began at initiation of study drug and up to follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMS-986004 75mg IV	0 of 5 (0%)	1 of 5 (20%)	0 of 5
BMS-986004 225mg IV	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
BMS 675mg	2 of 5 (40%)	5 of 5 (100%)	0 of 5
BMS 1500mg	1 of 10 (10%)	9 of 10 (90%)	1 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.

Related trials for Immune Thrombocytopenic Purpura

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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

20 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986004 75 mg IV, BMS-986004 225 mg IV and BMS-986004 675 mg IV in people with Immune Thrombocytopenic Purpura, run by Bristol-Myers Squibb at 20 sites in 8 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 1 inclusion and 2 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, United Kingdom, Poland, Australia, Russia and 3 more countries. 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?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term (time frame: Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)). The study lists 3 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 NCT02273960.

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 16 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.