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A Phase Ib Study of HMPL-523 in Immune Thrombocytopenia Patients

2019-05-20 19:54:21 | BioPortfolio

Summary

This is a radomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. The trial has two parts: dose escalation (stage 1) and dose expansion (stage 2). No cross-over treatment will be allowed during the study.

Description

Approximate 51 to 60 patients will be enrolled in dose ascelation (3 cohorts, 8 subjects each with the ratio of 3:1 vs Placebo) and dose expansion (1 cohort, 27-36 subjects with the ratio of 2:1 vs Placebo).

Study Design

Conditions

Immune Thrombocytopenia

Intervention

HMPL-523, Placebo

Location

Blood diseases hospital, Chinese academy of medical university
Tianjin
Tianjin
China
300000

Status

Not yet recruiting

Source

Hutchison Medipharma Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-05-20T19:54:21-0400

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PubMed Articles [6028 Associated PubMed Articles listed on BioPortfolio]

Involvement of Interferon-γ + 874A/T Polymorphism in the Pathogenesis of and Therapeutic Response to Immune Thrombocytopenia.

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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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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