SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer

NCT02600390 | Completed Phase 2 DMC

• 1 other identifier: SGSC-009
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.

Conditions

Leg Ulcer

Keywords

Leg Ulcer; LU; SANGUINATE; QOL; SCD; Sickle Cell Disease; Sickle Cell; Anemia; Leg Wound; Leg; Skin Lesion

Outcome Measures

Primary Outcomes (3)

• Safety of treatment as determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events

  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

  8 or 10 weeks

• Rate and extent of leg ulcer wound healing as measured by change in wound surface area

  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)

  8 or 10 weeks

• Changes in leg ulcer wound status as measured by extent of exudate production

  8 or 10 weeks

• Changes in leg ulcer wound status as measured by type and amount of granulation tissue

  8 or 10 weeks

• Changes in leg ulcer wound status as measured by overall change in leg ulcer wound appearance

  8 or 10 weeks

• Change in local skin in the region of the leg ulcer as measured by skin appearance (coloration, inflammation, etc.)

  8 or 10 weeks

Study Arms (2)

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.

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.

Biological: SANGUINATE

Interventions

SANGUINATE BIOLOGICAL

A two-hour infusion provided once a week over a 4-week or 6-week period.

SANGUINATE™ (4-week); SANGUINATE™ (6-week)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (2)

General Hospital Plaza de la Salud

Santo Domingo, Dominican Republic

Location

Centro Hemato-Oncologico

Marbella, Panama

Location

MeSH Terms

Conditions

Leg Ulcer; Anemia, Sickle Cell; Anemia

Interventions

PEGylated carboxyhemoglobin bovine

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hemant Misra, PhD

  Prolong Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 9, 2015
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1); PA (1)