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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006081-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Swedish Orphan Biovitrum | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients treated with Sym001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sym001 | Drug | Each cohort will receive one single dose of Sym001 according the assigned dose level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) | 6 weeks post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of platelet counts | From day 1 through week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Von Depka Prondzinski, PD Dr. | Werlhoff Institut Hannover, Germany | Principal Investigator |
| Ann Janssens, Dr. | ZU Gasthuisberg, Leuven, Belgium | Principal Investigator |
| Javier Loscertales Pueyo, Dra | Hospital La Princesa, Madrid, Spain | Principal Investigator |
| Wieslaw Wiktor Jedrzrjczak, Prof. | Katedra i klinika Hematologii, Warszawa, Poland | Principal Investigator |
| Andrei Cucucianu, Dr. | Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania | Principal Investigator |
| Marie Scully, Prof. Dr. MD | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ Nebraska Med Ctr. UNMC, 1005 | Omaha | Nebraska | 68198-7680 | United States | ||
| Hospital of the University of Pennsylvania, Site 1002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22915649 | Result | Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Roman MT, Jarque I, Loscertales J, Rus GP, Hellmann A, Jedrzejczak WW, Kuliczkowski K, Golubovic LM, Celeketic D, Cucuianu A, Gheorghita E, Lazaroiu M, Shpilberg O, Attias D, Karyagina E, Svetlana K, Vilchevska K, Cooper N, Talks K, Prabhu M, Sripada P, Bharadwaj TP, Naested H, Skartved NJ, Frandsen TP, Flensburg MF, Andersen PS, Petersen J. Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. Blood. 2012 Nov 1;120(18):3670-6. doi: 10.1182/blood-2012-06-438804. Epub 2012 Aug 20. |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 2085 Henry Tecklenburg Drive, 1001 | Charleston | South Carolina | 29414 | United States |
| Research Site 3203 | Bruges | Belgium |
| Research Site 3202 | Leuven | Belgium |
| Research Site 3201 | Yvoir | Belgium |
| Research Site 4906, 4907 | Berlin | Germany |
| Research Site 4902 | Cologne | Germany |
| Research Site 4903 | Duisburg | Germany |
| Research Site 4905 | Essen | Germany |
| Reseach Site 4908 | Halle | Germany |
| Research Site 4901 | Hanover | Germany |
| Research Site 4904 | Regensburg | Germany |
| St. John's Medical College Hospital, 9106 | Bangalore | 560034 | India |
| MS Ramaiah Memorial Hospital, 9108 | Bangalore | 560054 | India |
| Narayana Hrudayalaya Hospitals, 9105 | Bangalore | 560099 | India |
| Columbia Asia Referral Hospital-Yeshwanthpur, 9101 | Bangalore | 576104 | India |
| Aysha Hospital Pvt. Ltd., 9109 | Chennai | 600010 | India |
| Apollo Hospital, 9104 | Hyderabad | 500033 | India |
| Kasturba Medical College Hospital, 9103 | Udupi | 576104 | India |
| Bnai-Zion Medical Center, 9721 | Haifa | 31048 | Israel |
| Rambam Medical Center, 9723 | Haifa | 35254 | Israel |
| The Edith Wolfson Medical Center, 9725 | Holon | 58100 | Israel |
| Western Galilee - Nahariya Hospital, 9722 | Nahariya | 22100 | Israel |
| Rabin Medical Center, 9724 | Petah Tikva | 49100 | Israel |
| Tel-Aviv Sourasky Medical Center, 9726 | Tel Aviv | 64239 | Israel |
| Research site 4801 | Gdansk | Poland |
| Research Site 4806 | Krakow | Poland |
| Research Site 4805 | Lodz | Poland |
| Instytut Hematologii i Transfuzjologii, 4807 | Warsaw | Poland |
| Research Site 4802, 4808 | Warsaw | Poland |
| Research Site 4803 | Warszava | Poland |
| Research Site 4804 | Wroclaw | Poland |
| Brasov Country Hospital, 4002 | Brasov | Romania |
| Institutul Clinic Fundeni, 4003 | Bucharest | Romania |
| "Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001 | Cluj-Napoca | Romania |
| Spitalul Clinic de Urgente Sfantu Spiridon, 4004 | Iași | Romania |
| Regional Clinical Hospital of Nizhny Novgorod, 7003 | Nizhny Novgorod | 603126 | Russia |
| Saint Petersburg State Institution Of Healthcare, 7001 | Saint Petersburg | 198205 | Russia |
| Regional Clinical Hospital na MI Kalinin, 7005 | Samara | 443095 | Russia |
| State Healthcare Institution Tula Regional Clin. Hosp., 7002 | Tula | 300053 | Russia |
| Clinical Center Nis 3802 | Niš | 18000 | Serbia |
| Clinical center Vojvodina 3801 | Novi Sad | 2100 | Serbia |
| Clinical Center Zemun 3803 | Zemun | 11080 | Serbia |
| Reseach Site 3403 | Barcelona | Spain |
| Hospital Gregorio Maranon, 3405 | Madrid | Spain |
| Hospital La Princesa, 3404 | Madrid | Spain |
| Research Site 3401 | Madrid | Spain |
| Research Site 3402 | Valencia | Spain |
| Cherkassy regional oncology center, 3906 | Cherkassy | 180009 | Ukraine |
| Gusak Academy of AMS Ukraine, 3905 | Donetsk | 83045 | Ukraine |
| Khmelnytskyi Regional Hospital, 3903 | Khmelnytskyi | 29000 | Ukraine |
| City Hospital #9 Kyiv Clinical Hospital, 3904 | Kiev | 04112 | Ukraine |
| Vinnytsya Regional Clinical Hospital, 3902 | Vinnytsia | 21018 | Ukraine |
| St. James's University Hospital, 4403 | Leeds | LS9 7TF | United Kingdom |
| Hammersmith Hosptial, 4402 | London | W12 OHS | United Kingdom |
| University College, 4401 | London | WC1E 6HX | United Kingdom |
| Royal Victoria Infirmery, 4404 | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Singleton Hospital, 4405 | Swansea | SA2 8QL | United Kingdom |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C558236 | rozrolimupab |
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