A study to assess the safety and effectiveness of the study drug (SM101) versus a placebo (dummy treatment) in adult patients with chronic Primary Immune Thrombocytopenia (ITP).

• Conditions: Primary Immune Thrombocytopenia; MedDRA version: 14.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-014842-28-DE
• Lead Sponsor: SuppreMol GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-21
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Subject has provided written informed consent prior to any study-related procedure
2. Male or female subjects aged 18 to 75, with or without splenectomy
3. Diagnosis of persistent or chronic Adult Primary Immune thrombocytopenia (ITP) based on subject’s history, physical examination, blood count and blood film examination according to the international consensus report guidelines with at least 3 months ITP history
4. Subjects > 60 years of age at the time point of ITP diagnosis, must have had a documented history of chronic ITP with a bone marrow report to confirm the diagnosis
5. Subject has previously received at least one ITP therapy
6. All other previously completed ITP treatment must achieve at least 5 time their terminal half-life prior to first administration of IMP
7. Concurrent ITP corticosteroid dose, if any, has been stable for 4 weeks preceding the first dose of IMP, and is intended to remain stable during the IMP treatment period
8. Platelet count less than 30,000/µL from at least 2 measurements within 4 weeks prior to first investigational medicinal product (IMP) administration. The second measurement should not be older than 1 week. Both measurements should be at least 1 week apart.
9. Patients with a body weight = 100 kg
10. Adequate liver and kidney function (as detailed in the protocol)
11. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1, with a life expectancy of at least 6 months
12. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 1 week prior to first IMP administration
13. Both WOCBP and men must use a medically acceptable method of contraception (Appendix III) prior to inclusion and throughout the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

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 caused by: previously diagnosed or possible high risk of conditions that may be associated with autoimmune thrombocytopenia, liver diseases, drugs, bone marrow diseases, recent transfusions, inherited thrombocytopenia, etc.
3. Subjects with confirmed HIV, hepatitis B or C infection.
4. Subjects with other acute infections within 4 weeks preceding the first dose of IMP
5. Subject received intravenous immunoglobulins (IVIGs) or anti-D antibody treatment within 4 weeks preceding the first dose of IMP
6. Subject received rituximab or any other B-cell depleting agent within 24 months preceding the first dose of IMP
7. Subject receives concomitant ITP medication other than corticosteroids, except rescue medication during the clinical trial
8. Splenectomy within 4 weeks prior to screening
9. Subject received or is planning to receive a haematopoietic stem cell transplantation during the clinical trial
10. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures
11. Known hypersensitivity to any recombinant E. coli-derived product or IMP excipients (Tween, Mannitol)
12. Subjects participating in a concurrent clinical trial or treated with another investigational drug within 4 weeks or 5 terminal half-lives of the drug (whichever is longer) preceding the first dose of IMP
13. History of or current alcohol or drug abuse
14. Any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study
15. Subjects with an active malignancy
16. Subjects with active, serious, life-threatening disease with a life expectancy of less than 6 months
17. Subject was previously treated with SM101 or corresponding placebo.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified