Leg UlcerPhase 2LUNCT02600390
SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer
A Phase 2 study testing SANGUINATE in people with Leg Ulcer, run by Prolong Pharmaceuticals at 2 sites in 2 countries.
Trial summary
SANGUINATE™ Sickle Cell Disease associated Leg Ulcers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leg Ulcer
- 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
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2016to Nov 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Properly consented patients suffering from Sickle Cell Disease (Hb-SS or Hb- Sβ° genotype) associated Leg ulcer.
- Presence of leg ulcer for at least 4 weeks
- Venous Clinical Severity Score of moderate to severe (defined as ≥12)
- Leg ulcer below the knee
Who cannot join
- Patient presenting with a clinically \& laboratory confirmed bacterial, fungal or acid fast organisms
- Patient has a recent acute complication of Sickle Cell Disease (e.g., pain crisis within 7 days, or acute chest syndrome within 21 days)
- Patient is planning to be pregnant, is pregnant, or is breast-feeding
- Presence of moderate to severe renal insufficiency (CrCl < 30 mL/min) or chronic kidney disease, or of moderate to severe hepatic insufficiency (Child-Pugh class B or C)
- Patients with more than 3 times the upper limit of normal laboratory reference range
- Concurrent or recent prior treatment (within 90 days) with an investigational medication
- Patients currently receiving treatment with hydroxyurea must be on stable dose for at least 30 days
- Receipt of a blood transfusion within 21 days
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Dominican Republic1 site
General Hospital Plaza de la Salud
Santo Domingo
About this study
Official title: An Open-label, Repeated-dose, Dose Escalation Study of the Safety and Effectiveness of SANGUINATE™ for the Treatment of Leg Ulcers in Adult Patients With Sickle Cell Disease
SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.
Read the detailed description
This is an escalating, repeated-dose, open-label Phase 2 study to test SANGUINATE (pegylated carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with Sickle Cell Disease (SCD leg ulcer).
Patients will undergo consent and screening procedures at the time of presentation for leg ulcer treatment. Eligible patients will begin a 3-week Run-In Period. A total of approximately fifteen (15) patients are expected to be screened in order to achieve an enrollment target of ten (10) evaluable patients for participation in the study. Evaluable is defined as a patient receiving a minimum of three doses of investigational product. Five (5) patients (Cohort 1) will receive four (4) once-weekly 2-hour IV infusions of SANGUINATE at a dose of 320 mg/kg (8 mL). An additional five (5) patients (Cohort 2) will receive six (6) once-weekly 2-hour IV infusions of SANGUINATE also at a dose of 320 mg/kg. Each patient will be contacted by telephone approximately 24 hours after dosing to verify the safety status of the patient. One week following the Treatment Phase, patients will return to the study center for a Final Visit where safety assessments will be performed. During the Final Visit, patients will receive standard of care treatment of ulcer. All patients will receive once-weekly Standard of Care (SOC) therapy for SCD leg ulcer for the duration of the study. SOC includes dressing the wound with multi-layer, short stretch, compression bandaging. Non-adherent, medical-grade foam will be used as the wound contact layer and primary dressing.
- Conditions
- Leg Ulcer
- Being tested
- SANGUINATE
- Keywords
- Leg Ulcer, LU, SANGUINATE, QOL, SCD, Sickle Cell Disease, Sickle Cell, Anemia, Leg Wound, Leg, Skin Lesion
- Medical subject headings
- Leg Ulcer, Anemia, Sickle Cell, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATEBiological
A two-hour infusion provided once a week over a 4-week or 6-week period.
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE™ (4-week) | Experimental | This is an Open-label, repeated-dose study. About five patients will be observed for 3 weeks continuing on standard of care therapy (for wound cleaning and bandaging). This will be followed by a 4-week treatment period to include once weekly doses of SANGUINATE provided via two-hour IV infusion. The final week of the study will include another observation period wherein all patients will receive standard of care therapy. Receives: Biological: SANGUINATE |
| SANGUINATE™ (6-week) | Experimental | This is an Open-label, repeated-dose study. About five patients will be observed for 3 weeks continuing on standard of care therapy (for wound cleaning and bandaging). This will be followed by a 6-week treatment period to include once weekly doses of SANGUINATE provided via two-hour IV infusion. The final week of the study will include another observation period wherein all patients will receive standard of care therapy. Receives: Biological: SANGUINATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment as determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Measured: 8 or 10 weeks
Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale, relative to non-wound site pain scores
Measured: 8 or 10 weeks
Rate and extent of leg ulcer wound healing as measured by change in wound surface area
Measured: 8 or 10 weeks
Secondary outcomes (8)
Changes in leg ulcer wound status as measured by need for debridement (type and quantity of non-viable tissue)
Measured: 8 or 10 weeks
Changes in leg ulcer wound status as measured by extent of exudate production
Change in quality of life as measured by SF-12 Health Survey (acute version) as well as other indicators of patient comfort and well-being
Measured: 8 or 10 weeks
Changes in leg ulcer wound status as measured by type and amount of granulation tissue
Measured: 8 or 10 weeks
Changes in leg ulcer wound status as measured by overall change in leg ulcer wound appearance
Measured: 8 or 10 weeks
Change in local skin in the region of the leg ulcer as measured by skin appearance (coloration, inflammation, etc.)
Measured: 8 or 10 weeks
Change in local skin in the region of the leg ulcer as measured by skin temperature (relative to body temperature)
Measured: 8 or 10 weeks
Improvement in leg ulcer wound severity as measured by Venous Clinical Severity Score (VCSS)
Measured: 8 or 10 weeks
Change in quality of life, as measured by an SF-12 Health Survey (acute version) as well as other indicators of patient comfort and well-being
Measured: 8 or 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hemant Misra, PhD, Study director, Prolong Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600390
- Sponsor's protocol ID
- SGSC-009
- Acronym
- LU
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2015
- Last updated
- 28 Feb 2017
- 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 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Repeated-dose, Dose Escalation Study of the Safety and Effectiveness of SANGUINATE™ for the Treatment of Leg Ulcers in Adult Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02600390
- Acronym / sponsor ID
- LU / SGSC-009
- Conditions
- Leg Ulcer
- Keywords
- Leg Ulcer, LU, SANGUINATE, QOL, SCD, Sickle Cell Disease, Sickle Cell, Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Nov 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.
SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.
Detailed description
This is an escalating, repeated-dose, open-label Phase 2 study to test SANGUINATE (pegylated carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with Sickle Cell Disease (SCD leg ulcer).
Patients will undergo consent and screening procedures at the time of presentation for leg ulcer treatment. Eligible patients will begin a 3-week Run-In Period. A total of approximately fifteen (15) patients are expected to be screened in order to achieve an enrollment target of ten (10) evaluable patients for participation in the study. Evaluable is defined as a patient receiving a minimum of three doses of investigational product. Five (5) patients (Cohort 1) will receive four (4) once-weekly 2-hour IV infusions of SANGUINATE at a dose of 320 mg/kg (8 mL). An additional five (5) patients (Cohort 2) will receive six (6) once-weekly 2-hour IV infusions of SANGUINATE also at a dose of 320 mg/kg. Each patient will be contacted by telephone approximately 24 hours after dosing to verify the safety status of the patient. One week following the Treatment Phase, patients will return to the study center for a Final Visit where safety assessments will be performed. During the Final Visit, patients will receive standard of care treatment of ulcer. All patients will receive once-weekly Standard of Care (SOC) therapy for SCD leg ulcer for the duration of the study. SOC includes dressing the wound with multi-layer, short stretch, compression bandaging. Non-adherent, medical-grade foam will be used as the wound contact layer and primary dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE™ (4-week) | Experimental | Biological: SANGUINATEThis is an Open-label, repeated-dose study. About five patients will be observed for 3 weeks continuing on standard of care therapy (for wound cleaning and bandaging). This will be followed by a 4-week treatment period to include once weekly doses of SANGUINATE provided via two-hour IV infusion. The final week of the study will include another observation period wherein all patients will receive standard of care therapy. |
| SANGUINATE™ (6-week) | Experimental | Biological: SANGUINATEThis is an Open-label, repeated-dose study. About five patients will be observed for 3 weeks continuing on standard of care therapy (for wound cleaning and bandaging). This will be followed by a 6-week treatment period to include once weekly doses of SANGUINATE provided via two-hour IV infusion. The final week of the study will include another observation period wherein all patients will receive standard of care therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Properly consented patients suffering from Sickle Cell Disease (Hb-SS or Hb- Sβ° genotype) associated Leg ulcer.
- Presence of leg ulcer for at least 4 weeks
- Venous Clinical Severity Score of moderate to severe (defined as ≥12)
- Leg ulcer below the knee
Key exclusion criteria (8 listed)
- Patient presenting with a clinically \& laboratory confirmed bacterial, fungal or acid fast organisms
- Patient has a recent acute complication of Sickle Cell Disease (e.g., pain crisis within 7 days, or acute chest syndrome within 21 days)
- Patient is planning to be pregnant, is pregnant, or is breast-feeding
- Presence of moderate to severe renal insufficiency (CrCl < 30 mL/min) or chronic kidney disease, or of moderate to severe hepatic insufficiency (Child-Pugh class B or C)
- Patients with more than 3 times the upper limit of normal laboratory reference range
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 |
|---|---|---|
| SANGUINATEA two-hour infusion provided once a week over a 4-week or 6-week period. | Biological | SANGUINATE™ (4-week), SANGUINATE™ (6-week) |
Primary outcome
Safety of treatment as determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Time frame: 8 or 10 weeks
Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale, relative to non-wound site pain scores
Time frame: 8 or 10 weeks
Rate and extent of leg ulcer wound healing as measured by change in wound surface area
Time frame: 8 or 10 weeks
8 secondary outcomes
Changes in leg ulcer wound status as measured by need for debridement (type and quantity of non-viable tissue)
Time frame: 8 or 10 weeks
Changes in leg ulcer wound status as measured by extent of exudate production
Time frame: 8 or 10 weeks
Changes in leg ulcer wound status as measured by type and amount of granulation tissue
Time frame: 8 or 10 weeks
Changes in leg ulcer wound status as measured by overall change in leg ulcer wound appearance
Time frame: 8 or 10 weeks
Change in local skin in the region of the leg ulcer as measured by skin appearance (coloration, inflammation, etc.)
Time frame: 8 or 10 weeks
Change in local skin in the region of the leg ulcer as measured by skin temperature (relative to body temperature)
Time frame: 8 or 10 weeks
Improvement in leg ulcer wound severity as measured by Venous Clinical Severity Score (VCSS)
Time frame: 8 or 10 weeks
Change in quality of life, as measured by an SF-12 Health Survey (acute version) as well as other indicators of patient comfort and well-being
Time frame: 8 or 10 weeks
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 28 Feb 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.
Hemant Misra, PhD study director
Prolong Pharma
2 sites in 2 countries: 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 Leg Ulcer, run by Prolong Pharmaceuticals at 2 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Dominican Republic, 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 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?
Safety of treatment as determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events (time frame: 8 or 10 weeks). 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?
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 28 Feb 2017.