Sickle Cell DiseasePhase 1NCT01848925
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
A Phase 1 study testing SANGUINATE™ and Hydroxyurea in people with Sickle Cell Disease, run by Prolong Pharmaceuticals at 4 sites in 2 countries.
Trial summary
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- SANGUINATE™ and Hydroxyurea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2013to Aug 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Homozygous (HbSS) Sickle Cell Anemia;
- Hb levels: >6g/dL - <10g/dL;
- Age : >18 years old;
- Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history".
Who cannot join
- Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
- Allergic to Hydroxyurea;
- History of clinical significant disease, as determined by the Investigator;
- History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
- Screening assessments considered to be abnormal by the Investigator;
- Patient has sever pulmonary hypertension (index >3 meters per sec);
- Donated blood within 60 days of screening or otherwise experienced blood loss of >250 mL within the same period;
- Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Colombia3 sites
Fundacion BIOS
Barranquilla
Fundacion Reina Isabel
Cali
Hospital Pablo TobinUribe
Medellín
About this study
Official title: A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
- Conditions
- Sickle Cell Disease
- Being tested
- SANGUINATE™, Hydroxyurea
- Keywords
- SANGUINATE
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATE™Biological
40 mg/mL intravenous infusion.
HydroxyureaDrug
Also called Hydroxycarbamide, Brand Names includes: Hydria, Droxia.
Standard of care for Sickle Cell treatment, 15 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE™ | Experimental | PEG-bHb-CO Receives: Biological: SANGUINATE™ |
| Hydroxyurea | Active comparator | Standard of care for Sickle Cell treatment, 15 mg/kg. Receives: Drug: Hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenny M Galvez, MD, Principal investigator, Hospital Pablo Tobin UribeLuis F Uribe, MD, Principal investigator, Fundacion Reina IsabelNestor Sosa, MD, Principal investigator, Hospital Punta PacificaAngel Hernandez, MD, Principal investigator, Fundacion BIOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848925
- Sponsor's protocol ID
- SGSC-003
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
- ClinicalTrials.gov ID
- NCT01848925
- Acronym / sponsor ID
- SGSC-003
- Conditions
- Sickle Cell Disease
- Keywords
- SANGUINATE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 May 2013 (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.
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE™ | Experimental | Biological: SANGUINATE™PEG-bHb-CO |
| Hydroxyurea | Active comparator | Drug: HydroxyureaStandard of care for Sickle Cell treatment, 15 mg/kg. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Homozygous (HbSS) Sickle Cell Anemia;
- Hb levels: >6g/dL - <10g/dL;
- Age : >18 years old;
- Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history".
Key exclusion criteria (8 listed)
- Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
- Allergic to Hydroxyurea;
- History of clinical significant disease, as determined by the Investigator;
- History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
- Screening assessments considered to be abnormal by the Investigator;
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™40 mg/mL intravenous infusion. | Biological | SANGUINATE™ |
| HydroxyureaAlso: Hydroxycarbamide, Brand Names includes: Hydria, Droxia.Standard of care for Sickle Cell treatment, 15 mg/kg. | Drug | Hydroxyurea |
Primary outcome
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
Time frame: 7 days
Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.
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 3 Dec 2014.
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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.
Kenny M Galvez, MD principal investigator
Hospital Pablo Tobin Uribe
Luis F Uribe, MD principal investigator
Fundacion Reina Isabel
Nestor Sosa, MD principal investigator
Hospital Punta Pacifica
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SANGUINATE™ and Hydroxyurea in people with Sickle Cell Disease, run by Prolong Pharmaceuticals at 4 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 4 inclusion and 8 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Colombia, Panama. 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?
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients. (time frame: 7 days). 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 3 Dec 2014.