Sickle Cell AnemiaPhase 3NCT02433158

Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

A Phase 3 study testing Rivipansel in people with Sickle Cell Anemia and Sickle Cell Disease, run by GlycoMimetics Incorporated at 97 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders
What is being tested?: Rivipansel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 97 sitesin 2 countries
Study dates: 16 Dec 2015to 15 Nov 2019
Phase: Phase 3
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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Completion of Study B5201002.
Documented diagnosis of SCD.
At least 6 years of age.
Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
Diagnosis of VOC necessitating IV opioids and admission to the hospital.
Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.

Who cannot join

Non-compliance with study procedures in the double blind study (B5201002).
Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
Clinically significant deterioration in renal function in Study B5201002.
Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Active use of illicit drugs and/or alcohol dependence.

Trial locations and contacts

97 sites in 2 countries.

Country

City, postcode or hospital

97 sites in 2 countries

United States85 sites

Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
Atlanta, Georgia, 30303
Grady Health System
Atlanta, Georgia, 30303
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
Atlanta, Georgia, 30322
Emory Children's Center
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/
Atlanta, Georgia, 30342
Children's Healthcare of Atlanta: Scottish Rite Campus
Atlanta, Georgia, 30342
University of Maryland Medical System Investigational Pharmacy
Baltimore, Maryland, 21201
University of Maryland Medical System
Baltimore, Maryland, 21201
Johns Hopkins Department of Medicine Clinical Trials Unit
Baltimore, Maryland, 21205
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
The Johns Hopkins Hospital Department of Pharmacy Services
Baltimore, Maryland, 21287-6180
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Boston Children's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Center for Clinical Investigation, Brigham and Women's Hospital
Boston, Massachusetts, 02115
Investigational Drug Services
Boston, Massachusetts, 02115
Kings County Hospital Center
Brooklyn, New York, 11203
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, 11203
SUNY Downstate Medical Center University Hospital of Brooklyn
Brooklyn, New York, 11203
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
Charleston, South Carolina, 29425
Medical University of South Carolina-Hospital
Charleston, South Carolina, 29425
Medical University of South Carolina
Charleston, South Carolina, 29425
MUSC Investigational Drug Services
Charleston, South Carolina, 29425
The University of Chicago/Comer Children's Hospital
Chicago, Illinois, 60637
University of Chicago, Investigational Drug Service Pharmacy
Chicago, Illinois, 60637
University of Cincinnati - Hoxworth Building
Cincinnati, Ohio, 45219
University of Cincinnati Medical Center / Investigational Pharmacy
Cincinnati, Ohio, 45219
University of Cincinnati Medical Center / Research Office
Cincinnati, Ohio, 45219
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
University of Cincinnati Physicians Company LLC
Cincinnati, Ohio, 45219
UC Health Ridgeway Hospital
Cincinnati, Ohio, 45229
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43203
The Ohio State University Wexner Center East
Columbus, Ohio, 43203
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
Columbus, Ohio, 43210
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke University Hospital, Investigational Drug Service
Durham, North Carolina, 27710
Duke University Medical Center
Durham, North Carolina, 27710
Golisano Childrens Hospital of Southwest Florida
Fort Myers, Florida, 33908
Cook Children's Hematology and Oncology Center
Fort Worth, Texas, 76104
Cook Children's Medical Center
Fort Worth, Texas, 76104
Cook Children's Hematology and Oncology Center-Grapevine
Grapevine, Texas, 76051
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
Vidant Medical Center
Greenville, North Carolina, 27834
University of Texas Medical School
Houston, Texas, 77030
University of Mississippi Medical Center - Outpatient Clinical Research Unit
Jackson, Mississippi, 39216
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Arkansas Children's Hospital Research Pharmacy
Little Rock, Arkansas, 72202
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Columbia University Medical Center Research Pharmacy
New York, New York, 10032
MS CHONY Pediatric Emergency Department
New York, New York, 10032
MS CHONY Pediatric Hematology/Oncology Unit
New York, New York, 10032
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Rhode Island Hospital-Pharmacy Service
Providence, Rhode Island, 02903
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Main Hospital-VCU
Richmond, Virginia, 23298
Virginia Commonwealth University - Investigational Drug Services
Richmond, Virginia, 23298
Virginia Commonwealth University- Clinical Research Services Unit
Richmond, Virginia, 23298
UC Davis Medical Center Main Hospital
Sacramento, California, 95817
University of California Davis Medical Center
Sacramento, California, 95817
Primary Children's Hospital Laboratory
Salt Lake City, Utah, 84113
Primary Children's Hospital
Salt Lake City, Utah, 84113
Memorial Family Medicine Center
Savannah, Georgia, 31404
Memorial Health University Medical Center
Savannah, Georgia, 31404
Center for Outpatient Health
St Louis, Missouri, 63108
Barnes-Jewish Hospital Department of Pharmacy
St Louis, Missouri, 63110
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Center for Advanced Medicine
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Jacobi Medical Center
The Bronx, New York, 10461
Howard University Center for Sickle Cell disease
Washington D.C., District of Columbia, 20001
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Howard University Hospital
Washington D.C., District of Columbia, 20060
St. Mary's Medical Center
West Palm Beach, Florida, 33407

Other trials in United States

Canada12 sites

Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Miseracordia Community Hospital
Edmonton, Alberta, T5R 4H5
Kaye Edmonton Clinic 3C
Edmonton, Alberta, T6G 1Z1
University of Alberta Hospital, Pharmacy Services
Edmonton, Alberta, T6G 1Z1
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Research transition Facility
Edmonton, Alberta, T6G 2V2
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
The Montreal Children's Hospital / McGill University Health Centre
Montreal, Quebec, H4A3J1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: An Open-Label Extension Study to Evaluate the Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

Read the detailed description

This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

Conditions: Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Being tested: Rivipansel
Keywords: Rivipansel, GMI-1070, Selectin Inhibitor, SCD, VOC
Medical subject headings: Anemia, Sickle Cell, Vaso-Occlusive Crises

What participants receive

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

RivipanselDrug
Also called GMI-1070
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.

Study groups in NCT02433158
Study group	Role	What they receive
Cohort 1	Experimental	Includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg. Receives: Drug: Rivipansel
Cohort 2	Experimental	Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg). Receives: Drug: Rivipansel

What is being measured

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

Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
Measured: 18 months
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study.
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Measured: 18 months
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Measured: 18 months
Number (%) of subjects with serious adverse events (SAEs) over the study.
Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.
Measured: 18 months

Secondary outcomes (1)

Subject re hospitalization
Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.
Measured: 18 months

Timeline

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

16 Dec 201515 Nov 2019

First posted4 May 2015 (estimated)
Study start16 Dec 2015
Primary completion15 Nov 2019
Study completion15 Nov 2019

Why it stopped: The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.

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 Sickle Cell AnemiaStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02433158
Sponsor's protocol ID: B5201003
Status last verified: Feb 2021
First submitted: 29 Apr 2015
Last updated: 10 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.
PubMed 35981565

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

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

All Sickle Cell Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Extension Study to Evaluate the Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
ClinicalTrials.gov ID: NCT02433158
Acronym / sponsor ID: B5201003
Conditions: Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Keywords: Rivipansel, GMI-1070, Selectin Inhibitor, SCD, VOC
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.
Enrolment: 154 participants (actual)
Lead sponsor: GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
Study start: 16 Dec 2015 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 15 Nov 2019 (actual)
First posted: 4 May 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.

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: RivipanselIncludes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.
Cohort 2	Experimental	Drug: RivipanselIncludes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Completion of Study B5201002.
Documented diagnosis of SCD.
At least 6 years of age.
Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
Diagnosis of VOC necessitating IV opioids and admission to the hospital.

Key exclusion criteria (6 listed)

Non-compliance with study procedures in the double blind study (B5201002).
Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
Clinically significant deterioration in renal function in Study B5201002.
Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.

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
RivipanselAlso: GMI-1070Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.	Drug	Cohort 1, Cohort 2

Primary outcome

Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study.
Time frame: 18 months
Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study.
Time frame: 18 months
Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study
Time frame: 18 months
Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.
Number (%) of subjects with serious adverse events (SAEs) over the study.
Time frame: 18 months
Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.

1 secondary outcome

Subject re hospitalization
Time frame: 18 months

Results and safety

The study was stopped early (reason given: The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Derived from this study: PubMed 35981565Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.
Individual participant dataSharing planned: No

Related trials for Sickle Cell Anemia

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

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.

Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivipansel in people with Sickle Cell Anemia and Sickle Cell Disease, run by GlycoMimetics Incorporated at 97 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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 subjects with treatment emergent adverse events (TEAEs) over the study. (time frame: 18 months). The study lists 4 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 NCT02433158, 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 10 Feb 2021.