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SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer (LU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02600390
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Study Description
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Brief Summary:
SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.

Condition or disease Intervention/treatment Phase
Leg Ulcer Biological: SANGUINATE Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SANGUINATE™ (4-week)
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.
 Biological: SANGUINATE
A two-hour infusion provided once a week over a 4-week or 6-week period.
Experimental: SANGUINATE™ (6-week)
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.
 Biological: SANGUINATE
A two-hour infusion provided once a week over a 4-week or 6-week period.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Rate and extent of leg ulcer wound healing as measured by change in wound surface area [ Time Frame: 8 or 10 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in leg ulcer wound status as measured by extent of exudate production [ Time Frame: 8 or 10 weeks ]
    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

  3. Changes in leg ulcer wound status as measured by type and amount of granulation tissue [ Time Frame: 8 or 10 weeks ]
  4. Changes in leg ulcer wound status as measured by overall change in leg ulcer wound appearance [ Time Frame: 8 or 10 weeks ]
  5. 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 ]
  6. 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 ]
  7. Improvement in leg ulcer wound severity as measured by Venous Clinical Severity Score (VCSS) [ Time Frame: 8 or 10 weeks ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600390


Locations
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Dominican Republic
General Hospital Plaza de la Salud
Santo Domingo, Dominican Republic
Panama
Centro Hemato-Oncologico
Marbella, Panama
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
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Study Director: Hemant Misra, PhD Prolong Pharma
More Information
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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02600390    
Other Study ID Numbers: SGSC-009
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prolong Pharmaceuticals:
Leg Ulcer
LU
SANGUINATE
QOL
SCD
Sickle Cell Disease
 Sickle Cell
Anemia
Leg Wound
Leg
Skin Lesion
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Leg Ulcer
Ulcer
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Skin Ulcer
Skin Diseases