A phase Ib/IIa clinical trial to investigate the safety and efficacy of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of patients with chronic adult idiopathic thrombocytopenic purpura (ITP)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 51

Inclusion Criteria

1. Written informed consent prior to any study related procedure
2. Male or female subjects aged 18 to 75 years, with or without splenectomy
3. Diagnosis of chronic idiopathic thrombocytopenic purpura (ITP) based on subject's history, physical examination, blood count and blood film examination according to the British Society for Haematology (BSH) and American Society of Hematology (ASH) guidelines for at least 6 months
4. Subject has previously received at least one ITP therapy
5. Platelet count less than 30,000/µL from at least two measurements
6. Subjects greater than 60 years of age must have had a documented history of chronic ITP with a bone marrow report to confirm the diagnosis

Exclusion Criteria

1. Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
2. Secondary thrombocytopenia
3. Subject received rituximab or any other B-cell depleting agent within 24 months preceding the first dose of investigational medical product (IMP)
4. All other previously completed ITP treatment must achieve at least 5 times their terminal half-life prior to first administration of IMP
5. Subject receives concomitant ITP medication other than corticosteroids, except rescue medication during the clinical trial
6. Splenectomy within 4 weeks prior to screening
7. History of or current alcohol or drug abuse
8. Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence, severity, causality and seriousness of adverse events (AEs), laboratory results and AEs of special interest including bleeding events. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.<br><br>Adverse Events will be recorded at an ongoing basis at every visit performed throughout the study (dose escalation part: screening, week 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 18, 20; extension part: screening, week 1, 2, 3, 4, 5, 8, 12, 16).

Secondary Outcome Measures