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Dose-Escalation Study of SCD-101 in Sickle Cell Disease

2015-03-26 05:53:22 | BioPortfolio

Summary

The purpose of this study is to determine the safety and clinical effects of SCD-101 when given to adults with sickle cell disease. SCD-101 inhibits sickling of red blood cells containing Hb S (sickle hemoglobin) under low oxygen conditions, the underlying cause of sickle cell disease. SCD-101 may inhibit red blood cell sickling in patients with sickle cell disease and reduce symptoms and slow disease progression.

This study will evaluate the safety and antisickling activity of SCD-101 in up to 24 adults with sickle cell disease.

Description

This study is an open-label, non-randomized, non-placebo-controlled, single site, dose- escalation study of SCD-101 in participants with homozygous sickle cell disease (S/S) or S/beta 0 thalassemia. All participants will be monitored for safety, tolerability, and dose-limiting toxicities.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Sickle Cell Disease

Intervention

SCD-101

Location

King's County Hospital
Brooklyn
New York
United States
11203

Status

Recruiting

Source

Invenux, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-03-26T05:53:22-0400

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One of the sickle cell disorders characterized by the presence of both hemoglobin S and hemoglobin C. It is similar to, but less severe than sickle cell anemia.

An abnormal hemoglobin resulting from the substitution of valine for glutamic acid at position 6 of the beta chain of the globin moiety. The heterozygous state results in sickle cell trait, the homozygous in sickle cell anemia.

An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)

A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S.

The condition of being heterozygous for hemoglobin S.

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