Anemia, Sickle CellPhase 2NCT02411708
Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
A Phase 2 study testing SANGUINATE in people with Anemia, Sickle Cell, run by Prolong Pharmaceuticals at 9 sites in United States.
Trial summary
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- SANGUINATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Sickle Cell Disease (all genotypes),
- Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,
- Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,
- Able to provide written consent,
- Able to receive IV infusion of study drug.
Who cannot join
- In the judgment of the Investigator, the participant is not a good candidate for the study,
- An acute severe complication of SCD beyond VOC,
- Pregnant or actively trying to become pregnant, or breastfeeding,
- Participant had > 6 urgent visits for SCD complications in the prior 3 months,
- Fewer than 30 days since any prior treatment with IV pain medication for VOC,
- Onset of current acute painful crisis > 3 days prior to dosing,
Show all 9Show fewer
- Evidence of moderate to severe renal insufficiency (CrCl < 50 mL/min) or chronic kidney disease, or of moderate to severe hepatic disease (LFTs > 2 x ULN) based on past medical history,
- Concurrent or prior treatment within 90 days with an investigational medication,
- Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201-1559
Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland, 21205
Ohio State University Medical Center
Columbus, Ohio, 43203
FSCDR
Hollywood, Florida, 33021
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53226
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Rochester Medical Center
Rochester, New York, 14627-0140
Florida Health Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: A Phase 2 Study of the Safety and Effectiveness of SANGUINATE™ in the Treatment of Vaso-Occlusive Crises in the Ambulatory Setting: A Placebo-Controlled, Single-Dose, Single-Blind Study in Adults With Sickle Cell Disease
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis
Read the detailed description
Patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment and screening into the SGSC-005 study. Patients who meet all inclusion/exclusion criteria will be randomized to receive either SANGUINATE 320 mg/kg or placebo (saline) over a 2 hour infusion period. Assessments of vital signs, ECGs, safety labs, adverse events as well as patient and physician questionnaires will be completed up to 6 hours after the start of the infusion. Patients will then be assessed for discharge either to home or admitted to the hospital for further treatment depending on their disease severity. Follow-up phone calls will be completed 24 hours and 7 days after initiation of treatment . A follow-up visit will be completed in the clinic at 72 hours after initiation of treatment.
- Conditions
- Anemia, Sickle Cell
- Being tested
- SANGUINATE, Placebo
- 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.
SANGUINATEDrug
Also called pegylated carboxyhemoglobin bovine
Single two-hour infusion of SANGUINATE
PlaceboDrug
Also called Normal Saline
Single two-hour infusion of placebo
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE | Experimental | 320 mg/kg Receives: Drug: SANGUINATE |
| Placebo | Placebo comparator | Normal saline IV infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to readiness for discharge from ambulatory site
Defined as the time from the start of study drug infusion until the time of participant's response that their pain episode has improved enough for discharge; investigator's assessment of participant's readiness for discharge; and participant no longer requires IV opioid administration
Measured: 7 Days
Secondary outcomes (6)
Safety of treatment
as determined by changes in vital signs, EKG, biochemical, hematological, and urinalysis measures, and reported AEs
Measured: 1 Day
Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale
Measured: 1 Day
Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit
Measured: 1 Day
Global assessment of the participant's improvement by the Investigator or study staff (at the time of readiness for discharge from the ambulatory visit, and at the 72-hour follow-up visit)
Measured: 7 Days
Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge
Measured: 7 Days
Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge
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 Apr 2015 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411708
- Sponsor's protocol ID
- SGSC-005
- Status last verified
- May 2018
- First submitted
- 2 Apr 2015
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Safety and Effectiveness of SANGUINATE™ in the Treatment of Vaso-Occlusive Crises in the Ambulatory Setting: A Placebo-Controlled, Single-Dose, Single-Blind Study in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02411708
- Acronym / sponsor ID
- SGSC-005
- Conditions
- Anemia, Sickle Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Apr 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.
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis
Detailed description
Patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment and screening into the SGSC-005 study. Patients who meet all inclusion/exclusion criteria will be randomized to receive either SANGUINATE 320 mg/kg or placebo (saline) over a 2 hour infusion period. Assessments of vital signs, ECGs, safety labs, adverse events as well as patient and physician questionnaires will be completed up to 6 hours after the start of the infusion. Patients will then be assessed for discharge either to home or admitted to the hospital for further treatment depending on their disease severity. Follow-up phone calls will be completed 24 hours and 7 days after initiation of treatment . A follow-up visit will be completed in the clinic at 72 hours after initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE | Experimental | Drug: SANGUINATE320 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years,
- Sickle Cell Disease (all genotypes),
- Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,
- Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,
- Able to provide written consent,
Key exclusion criteria (9 listed)
- In the judgment of the Investigator, the participant is not a good candidate for the study,
- An acute severe complication of SCD beyond VOC,
- Pregnant or actively trying to become pregnant, or breastfeeding,
- Participant had > 6 urgent visits for SCD complications in the prior 3 months,
- Fewer than 30 days since any prior treatment with IV pain medication for VOC,
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 |
|---|---|---|
| SANGUINATEAlso: pegylated carboxyhemoglobin bovineSingle two-hour infusion of SANGUINATE | Drug | SANGUINATE |
| PlaceboAlso: Normal SalineSingle two-hour infusion of placebo | Drug | Placebo |
Primary outcome
Time to readiness for discharge from ambulatory site
Time frame: 7 Days
Defined as the time from the start of study drug infusion until the time of participant's response that their pain episode has improved enough for discharge; investigator's assessment of participant's readiness for discharge; and participant no longer requires IV opioid administration
6 secondary outcomes
Safety of treatment
Time frame: 1 Day
Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale
Time frame: 1 Day
Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit
Time frame: 1 Day
Global assessment of the participant's improvement by the Investigator or study staff (at the time of readiness for discharge from the ambulatory visit, and at the 72-hour follow-up visit)
Time frame: 7 Days
Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge
Time frame: 7 Days
Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge
Time frame: 7 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 23 May 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SANGUINATE in people with Anemia, Sickle Cell, run by Prolong Pharmaceuticals at 9 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 6 inclusion and 9 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 phase mean?
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?
Time to readiness for discharge from ambulatory site (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 23 May 2018.