Status:
COMPLETED
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Symphogen A/S
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
Immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 singl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00718692
Start Date
July 1 2008
End Date
October 1 2011
Last Update
January 30 2019
Active Locations (59)
Enter a location and click search to find clinical trials sorted by distance.
1
Univ Nebraska Med Ctr. UNMC, 1005
Omaha, Nebraska, United States, 68198-7680
2
Hospital of the University of Pennsylvania, Site 1002
Philadelphia, Pennsylvania, United States, 19104
3
2085 Henry Tecklenburg Drive, 1001
Charleston, South Carolina, United States, 29414
4
Research Site 3203
Bruges, Belgium