Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

Symphogen

Status and phase: Completed; Phase 2

Conditions: Immune Thrombocytopenic Purpura

Treatments: Drug: Sym001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718692

Sym001-03

2007-006081-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

1

Experimental group

Description:

Patients treated with Sym001

Treatment:

Drug: Sym001