Acute AnemiaPhase 1NCT02754999
A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.
A Phase 1 study testing SANGUINATE™ in people with Acute Anemia, run by Prolong Pharmaceuticals at 32 sites in United States.
Trial summary
In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Anemia
- What is being tested?
- SANGUINATE™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 32 sitesUnited States
- Study dates
- Mar 2016to 17 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs
- Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days
- Age ≥ 18 years
- Receiving or willing to receive supplemental iron therapy (unless contraindicated)
- Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy
- Patient or legally authorized representative provided consent to participate
- Investigator determination that the patient is an appropriate candidate for study enrollment
Who cannot join
- Hemoglobin ≤ 2 g/dL
- Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25)
- Unable to provide sufficient blood sample volume for screening assessments; or
- Pregnant; or
- Investigator determination that the patient is not an appropriate candidate for study enrollment
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Abington University
Abington, Pennsylvania, 19001
Augusta University
Augusta, Georgia, 30912
Kaiser Permanente
Baldwin Park, California, 91706
Johns Hopkins University
Baltimore, Maryland, 21287
Brookwood Princeton Baptist
Birmingham, Alabama, 35213
Medical University of South Carolina
Charleston, South Carolina, 29425
Presbyterian Hospital Novant Health
Charlotte, North Carolina, 28204
Detroit Medical Center Harper Univesity Hospital
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
University of Texas Medical Center (El Paso)
El Paso, Texas, 79905
Englewood Medical Center
Englewood, New Jersey, 07631
Bon Secour St Francis Cancer Center
Greenville, South Carolina, 29607
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Houston Methodist Hospital
Houston, Texas, 77030
St. Lukes
Houston, Texas, 77030
Northwell - North Shore University Hospital
Lake Success, New York, 11042
Antelope Valley Hospital
Lancaster, California, 93534
St. Barnabas
Livingston, New Jersey, 07039
Loma Linda Medical Center
Loma Linda, California, 92354
Wellstar Atlanta Medical Centre
Marietta, Georgia, 30066
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53214
Providence Holy Cross Hospital
Mission Hills, California, 91345
Mt. Sinai /Recanati/Miller Transplantation Institute, Icahn
New York, New York, 10029
Hahnemann University Hospital (Rittenhouse)
Philadelphia, Pennsylvania, 19106
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Yavapai Regional Medical Center
Prescott, Arizona, 86301
Virginia Commonwealth University
Richmond, Virginia, 23298
Swedish Medical Center
Seattle, Washington, 98122
Tampa General Hospital
Tampa, Florida, 33606
Medstar Georgetown University Hosiptal
Washington D.C., District of Columbia, 20007
About this study
Official title: An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion
In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.
Read the detailed description
Data collection for each patient during the in-patient portion of the study will be required for up to a maximum of 14 days while under critical care, with additional collection of safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each patient will thus have up to 28 days participation in the trial.
A minimum of 100 subjects are to be enrolled and to receive at least one infusion of SANGUINATE, with 14-day follow-up after the last infusion.
Because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.
- Conditions
- Acute Anemia
- Being tested
- SANGUINATE™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATE™Drug
Also called pegylated carboxyhemoglobin bovine
As needed (PRN) infusions of 500 mL of SANGUINATE
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE™ | Experimental | As Needed Dosing of SANGUINATE Receives: Drug: SANGUINATE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of adverse events within 24-hours of each SANGUINATE infusion
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events
Measured: 24 Hours
Secondary outcomes (6)
Percentage of patients who survive the acute episode of severe anemia
Measured: 14 Days
Percentage of patients who recover from hypoxia-induced abnormal end-organ function
Measured: 14 Days
Percentage of patients who improved with their hemodynamic status
Measured: 14 Days
Percentage of patients who discontinue inotrope therapy
Measured: 14 Days
Percentage of patients who discontinue respiratory support/therapy
Measured: 14 Days
Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days)
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported serious adverse events
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion17 May 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abe Abuchowski, PhD, Study director, Prolong Pharamceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754999
- Sponsor's protocol ID
- SGHY-001
- Status last verified
- May 2017
- First submitted
- 26 Apr 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion
- ClinicalTrials.gov ID
- NCT02754999
- Acronym / sponsor ID
- SGHY-001
- Conditions
- Acute Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 28 Apr 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.
In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.
Detailed description
Data collection for each patient during the in-patient portion of the study will be required for up to a maximum of 14 days while under critical care, with additional collection of safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each patient will thus have up to 28 days participation in the trial.
A minimum of 100 subjects are to be enrolled and to receive at least one infusion of SANGUINATE, with 14-day follow-up after the last infusion.
Because of the life-threatening effects of severe anemia, it is expected that all patients in this trial will receive care within a critical care facility (may be called intensive care or some similar name), wherein all patients will have real-time monitoring of vital signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE™ | Experimental | Drug: SANGUINATE™As Needed Dosing of SANGUINATE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient would otherwise receive RBC transfusion for treatment of severe anemia but cannot (hemolytic/allosensitized or no compatible blood) or will not (religious/personal objection) receive RBCs
- Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less than 7 days
- Age ≥ 18 years
- Receiving or willing to receive supplemental iron therapy (unless contraindicated)
- Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy
Key exclusion criteria (5 listed)
- Hemoglobin ≤ 2 g/dL
- Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity Score (NISS) Score ≥ 25)
- Unable to provide sufficient blood sample volume for screening assessments; or
- Pregnant; or
- Investigator determination that the patient is not an appropriate candidate for study enrollment
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 |
|---|---|---|
| SANGUINATE™Also: pegylated carboxyhemoglobin bovineAs needed (PRN) infusions of 500 mL of SANGUINATE | Drug | SANGUINATE™ |
Primary outcome
Number and severity of adverse events within 24-hours of each SANGUINATE infusion
Time frame: 24 Hours
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, death and other reported adverse events
6 secondary outcomes
Percentage of patients who survive the acute episode of severe anemia
Time frame: 14 Days
Percentage of patients who recover from hypoxia-induced abnormal end-organ function
Time frame: 14 Days
Percentage of patients who improved with their hemodynamic status
Time frame: 14 Days
Percentage of patients who discontinue inotrope therapy
Time frame: 14 Days
Percentage of patients who discontinue respiratory support/therapy
Time frame: 14 Days
Number of serious adverse events following the start of SANGUINATE infusions through the final visit (up to 28 days)
Time frame: 28 Days
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 27 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Abe Abuchowski, PhD study director
Prolong Pharamceuticals
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SANGUINATE™ in people with Acute Anemia, run by Prolong Pharmaceuticals at 32 sites 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 7 inclusion and 5 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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. 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 and severity of adverse events within 24-hours of each SANGUINATE infusion (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2017.