A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.

Symphogen A/S59 sites in 11 countries61 target enrollmentJuly 2008

ConditionsImmune Thrombocytopenic Purpura

InterventionsSym001

DrugsSym001

Overview

Phase: Phase 2
Intervention: Sym001
Conditions: Immune Thrombocytopenic Purpura
Sponsor: Symphogen A/S
Enrollment: 61
Locations: 59
Primary Endpoint: Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

October 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Symphogen A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmed presence of thrombocytopenia with platelet count \< 30,000/mm3 at the pre-dose visit.
•History of isolated ITP
•RhD-positive serology.
•Previous treatment and response to first line therapy for ITP

Exclusion Criteria

•Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
•Suspected infection with HIV, Hepatitis C, H. pylori.
•Clinical splenomegaly
•History of abnormal bone marrow examination.
•Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
•Underlying haemolytic condition
•History of splenectomy.
•Subject is pregnant, breast feeding or intends to become pregnant.