Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease

NCT00004408 | Completed Phase 3

• 3 other identifiers: 199/13296CYTRX-C97-1248CYTRX-FDR001433
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful vaso-occlusive crisis in patients with sickle cell disease. II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic use, and length of hospitalization of these patients.

Conditions

Sickle Cell Anemia

Keywords

disease-related problem/condition; genetic diseases and dysmorphic syndromes; hematologic disorders; pain; rare disease; sickle cell anemia

Interventions

poloxamer 188 DRUG

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Sickle cell disease confirmed by electrophoresis or high pressure liquid chromatography * At least one prior documented painful crisis episode but no greater than 10 crises per year for the last two years * Sudden onset of acute pain lasting 4-12 hours and involving at least one site * Severe crisis pain that requires parenteral analgesics and hospitalization, but not within the preceding 2 weeks --Prior/Concurrent Therapy-- * Surgery: At least 2 weeks since prior major surgery No concurrent surgery * Other: At least 2 weeks since prior puncture of noncompressible vessels No prior therapy using poloxamer 188 No concurrent investigational drug No concurrent use of nonsteroidal anti-inflammatory drugs --Patient Characteristics-- * Hematopoietic: No significant bleeding or bleeding disorder * Hepatic: ALT no greater than 2 times normal * Renal: No active renal disease Creatinine no greater than 1.0 mg/dL OR Creatinine clearance greater than 50 mL/min Protein less than 300 mg/dL * Cardiovascular: No evidence of acute myocardial ischemia or infarction * Neurologic: At least 6 months since prior cerebrovascular accident or seizure * Other: Not pregnant Fertile patients must use effective contraception during and for at least 30 days after treatment No history of chronic bacterial osteomyelitis No history of drug or alcohol abuse At least 6 months since prior use of illicit drug Have adequate IV access No crisis with life-threatening complications such as: Hepatic or splenic sequestration Acute chest syndrome Aplastic crisis No known infection or infection with encapsulated organism No evidence of septic shock Not concurrently hospitalized for other conditions Not concurrently on hypertransfusion program

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead
• CytRx: collaborator

Related Publications (1)

• Adams-Graves P, Kedar A, Koshy M, Steinberg M, Veith R, Ward D, Crawford R, Edwards S, Bustrack J, Emanuele M. RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: a pilot study. Blood. 1997 Sep 1;90(5):2041-6.

  PMID: 9292541 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Genetic Diseases, Inborn; Hematologic Diseases; Pain; Rare Diseases

Interventions

Poloxamer

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• R. Martin Emanuele

  CytRx

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: November 1, 1997
• Study Completion: November 1, 1999
• Last Updated: March 6, 2012

Record last verified: 2012-03