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An Open-label Safety Study of S-888711

2010-07-15 17:00:00 | BioPortfolio

Summary

This is a Phase 2, multicenter, open-label, dose-ranging, parallel-group extension study to evaluate the safety of S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate in this study must have completed the Phase 2 double-blind, randomized controlled study.

Study Design

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

Conditions

Immune Thrombocytopenia

Intervention

S-888711

Location

Investigator
Anaheim
California
United States
92801

Status

Recruiting

Source

Shionogi USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Medical and Biotech [MESH] Definitions

An antihelminthic drug that has been tried experimentally in rheumatic disorders where it apparently restores the immune response by increasing macrophage chemotaxis and T-lymphocyte function. Paradoxically, this immune enhancement appears to be beneficial in rheumatoid arthritis where dermatitis, leukopenia, and thrombocytopenia, and nausea and vomiting have been reported as side effects. (From Smith and Reynard, Textbook of Pharmacology, 1991, p435-6)

Thrombocytopenia occurring in the absence of toxic exposure or a disease associated with decreased platelets. It is mediated by immune mechanisms, in most cases IMMUNOGLOBULIN G autoantibodies which attach to platelets and subsequently undergo destruction by macrophages. The disease is seen in acute (affecting children) and chronic (adult) forms.

Regeneration of normal immune function after immune depleting procedures or infections (e.g., HEMATOPOIETIC STEM CELL TRANSPLANTATION). Delayed and incomplete reconstitution of the ADAPTIVE IMMUNE system in particular involving T-CELLS is associated with increase or relapse of infection.

A clinically recognized malformation condition caused by a distal 11q deletion. The features of the syndrome are growth retardation, psychomotor retardation, trigonocephaly, divergent intermittent strabismus, epicanthus, telecanthus, broad nasal bridge, short nose with anteverted nostrils, carp-shaped upper lip, retrognathia, low-set dysmorphic ears, bilateral camptodactyly, and hammertoes. Most patients have a THROMBOCYTOPENIA and platelet dysfunction known also as Paris-Trousseau type thrombocytopenia.

Alteration of the immune system or of an immune response by agents that activate or suppress its function. This can include IMMUNIZATION or administration of immunomodulatory drugs. Immunomodulation can also encompass non-therapeutic alteration of the immune system effected by endogenous or exogenous substances.

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