Immune Thrombocytopenic Purpura Clinical Trial
Official title:
A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.
Verified date | January 2019 |
Source | Symphogen A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 61 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site 3203 | Brugge | |
Belgium | Research Site 3202 | Leuven | |
Belgium | Research Site 3201 | Yvoir | |
Germany | Research Site 4906, 4907 | Berlin | |
Germany | Research Site 4903 | Duisburg | |
Germany | Research Site 4905 | Essen | |
Germany | Reseach Site 4908 | Halle | |
Germany | Research Site 4901 | Hannover | |
Germany | Research Site 4902 | Köln | |
Germany | Research Site 4904 | Regensburg | |
India | Columbia Asia Referral Hospital-Yeshwanthpur, 9101 | Bangalore | |
India | MS Ramaiah Memorial Hospital, 9108 | Bangalore | |
India | Narayana Hrudayalaya Hospitals, 9105 | Bangalore | |
India | St. John's Medical College Hospital, 9106 | Bangalore | |
India | Aysha Hospital Pvt. Ltd., 9109 | Chennai | |
India | Apollo Hospital, 9104 | Hyderabad | |
India | Kasturba Medical College Hospital, 9103 | Udupi | |
Israel | Bnai-Zion Medical Center, 9721 | Haifa | |
Israel | Rambam Medical Center, 9723 | Haifa | |
Israel | The Edith Wolfson Medical Center, 9725 | Holon | |
Israel | Western Galilee - Nahariya Hospital, 9722 | Nahariya | |
Israel | Rabin Medical Center, 9724 | Petach Tikva | |
Israel | Tel-Aviv Sourasky Medical Center, 9726 | Tel Aviv | |
Poland | Research site 4801 | Gdansk | |
Poland | Research Site 4806 | Krakow | |
Poland | Research Site 4805 | Lodz | |
Poland | Research Site 4803 | Warszava | |
Poland | Instytut Hematologii i Transfuzjologii, 4807 | Warszawa | |
Poland | Research Site 4802, 4808 | Warszawa | |
Poland | Research Site 4804 | Wroclaw | |
Romania | Brasov Country Hospital, 4002 | Brasov | |
Romania | Institutul Clinic Fundeni, 4003 | Bucuresti | |
Romania | "Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001 | Cluj-Napoca | |
Romania | Spitalul Clinic de Urgente Sfantu Spiridon, 4004 | Iasi | |
Russian Federation | Regional Clinical Hospital of Nizhny Novgorod, 7003 | Nizhny Novgorod | |
Russian Federation | Regional Clinical Hospital na MI Kalinin, 7005 | Samara | |
Russian Federation | Saint Petersburg State Institution Of Healthcare, 7001 | St. Petersburg | |
Russian Federation | State Healthcare Institution Tula Regional Clin. Hosp., 7002 | Tula | |
Serbia | Clinical Center Nis 3802 | Nis | |
Serbia | Clinical center Vojvodina 3801 | Novi Sad | |
Serbia | Clinical Center Zemun 3803 | Zemun | |
Spain | 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 | |
Ukraine | Cherkassy regional oncology center, 3906 | Cherkassy | |
Ukraine | Gusak Academy of AMS Ukraine, 3905 | Donetsk | |
Ukraine | Khmelnytskyi Regional Hospital, 3903 | Khmelnytskyi | |
Ukraine | City Hospital #9 Kyiv Clinical Hospital, 3904 | Kiev | |
Ukraine | Vinnytsya Regional Clinical Hospital, 3902 | Vinnytsya | |
United Kingdom | St. James's University Hospital, 4403 | Leeds | |
United Kingdom | Hammersmith Hosptial, 4402 | London | |
United Kingdom | University College, 4401 | London | |
United Kingdom | Royal Victoria Infirmery, 4404 | Newcastle Upon Tyne | |
United Kingdom | Singleton Hospital, 4405 | Swansea | |
United States | 2085 Henry Tecklenburg Drive, 1001 | Charleston | South Carolina |
United States | Univ Nebraska Med Ctr. UNMC, 1005 | Omaha | Nebraska |
United States | Hospital of the University of Pennsylvania, Site 1002 | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Symphogen A/S | Swedish Orphan Biovitrum |
United States, Belgium, Germany, India, Israel, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom,
Robak T, Windyga J, Trelinski J, von Depka Prondzinski M, Giagounidis A, Doyen C, Janssens A, Alvarez-Román MT, Jarque I, Loscertales J, Rus GP, Hellmann A, Jêdrzejczak WW, Kuliczkowski K, Golubovic LM, Celeketic D, Cucuianu A, Gheorghita E, Lazaroiu M, S — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) | 6 weeks post dosing | ||
Secondary | Measurements of platelet counts | From day 1 through week 6 |
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