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Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis

NCT01925001 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-10-28

No results posted yet for this study

Summary

Sickle Cell disease is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body. In Sickle Cell disease, as red blood cells circulate and oxygen is released, the deoxygenated abnormal Hemoglobin S can begin to polymerize and cause red cells to become sticky and elongated. These "sickled" red cells are less flexible and will obstruct small blood vessels and prevent normal red cells from circulating freely, which limits oxygen delivery to tissues and organs. This is known as a "sickling crisis" or "vaso-occlusive crisis" and is the leading cause of hospitalization in patients with Sickle Cell disease.

Patients suffering from a sickle crisis experience severe pain and are at risk of stroke, heart attack or even death. Current therapy is limited to hydration and symptomatic pain relief. The administration of MP4CO as an adjunct treatment to standard therapy may alleviate pain associated with a sickling crisis and potentially reduce the severity and duration of a crisis. This may shorten the time in hospital and potentially improve the quality of life for patients with sickle cell anemia.

Conditions

Interventions

DRUG

MP4CO

43 mg/mL pegylated carboxyhemoglobin \[≥ 90% CO hemoglobin saturation\] in physiological acetate electrolyte solution

DRUG

Sodium chloride solution

Normal saline solution (0.9% Sodium Chloride Injection USP)

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

  • Tania Small, MD · Sangart, Inc., San Diego, CA

  • Swee Lay Thein, MD · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • Bahrain
  • Belgium
  • Brazil
  • France
  • Lebanon
  • Netherlands
  • Qatar
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925001 on ClinicalTrials.gov