Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)
- Conditions
- Immune Thrombocytopenic Purpura
- Interventions
- Drug: Sym001
- Registration Number
- NCT00718692
- Lead Sponsor
- Symphogen A/S
- 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 single IV dose of Sym001.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Sym001 Patients treated with Sym001
- Primary Outcome Measures
Name Time Method Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) 6 weeks post dosing
- Secondary Outcome Measures
Name Time Method Measurements of platelet counts From day 1 through week 6
Trial Locations
- Locations (59)
Reseach Site 4908
🇩🇪Halle, Germany
Aysha Hospital Pvt. Ltd., 9109
🇮🇳Chennai, India
Apollo Hospital, 9104
🇮🇳Hyderabad, India
Univ Nebraska Med Ctr. UNMC, 1005
🇺🇸Omaha, Nebraska, United States
2085 Henry Tecklenburg Drive, 1001
🇺🇸Charleston, South Carolina, United States
Research Site 3203
🇧🇪Brugge, Belgium
Research Site 3202
🇧🇪Leuven, Belgium
St. John's Medical College Hospital, 9106
🇮🇳Bangalore, India
Research Site 4906, 4907
🇩🇪Berlin, Germany
Research Site 3201
🇧🇪Yvoir, Belgium
Kasturba Medical College Hospital, 9103
🇮🇳Udupi, India
Bnai-Zion Medical Center, 9721
🇮🇱Haifa, Israel
Rambam Medical Center, 9723
🇮🇱Haifa, Israel
Western Galilee - Nahariya Hospital, 9722
🇮🇱Nahariya, Israel
Rabin Medical Center, 9724
🇮🇱Petach Tikva, Israel
Tel-Aviv Sourasky Medical Center, 9726
🇮🇱Tel Aviv, Israel
Research site 4801
🇵🇱Gdansk, Poland
Spitalul Clinic de Urgente Sfantu Spiridon, 4004
🇷🇴Iasi, Romania
Regional Clinical Hospital of Nizhny Novgorod, 7003
🇷🇺Nizhny Novgorod, Russian Federation
Regional Clinical Hospital na MI Kalinin, 7005
🇷🇺Samara, Russian Federation
City Hospital #9 Kyiv Clinical Hospital, 3904
🇺🇦Kiev, Ukraine
Vinnytsya Regional Clinical Hospital, 3902
🇺🇦Vinnytsya, Ukraine
The Edith Wolfson Medical Center, 9725
🇮🇱Holon, Israel
"Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001
🇷🇴Cluj-Napoca, Romania
Royal Victoria Infirmery, 4404
🇬🇧Newcastle Upon Tyne, United Kingdom
Singleton Hospital, 4405
🇬🇧Swansea, United Kingdom
Research Site 4806
🇵🇱Krakow, Poland
Research Site 4903
🇩🇪Duisburg, Germany
Research Site 4901
🇩🇪Hannover, Germany
Hospital of the University of Pennsylvania, Site 1002
🇺🇸Philadelphia, Pennsylvania, United States
Research Site 4905
🇩🇪Essen, Germany
Research Site 4902
🇩🇪Köln, Germany
Research Site 4904
🇩🇪Regensburg, Germany
Narayana Hrudayalaya Hospitals, 9105
🇮🇳Bangalore, India
MS Ramaiah Memorial Hospital, 9108
🇮🇳Bangalore, India
Columbia Asia Referral Hospital-Yeshwanthpur, 9101
🇮🇳Bangalore, India
Research Site 4804
🇵🇱Wroclaw, Poland
Hammersmith Hosptial, 4402
🇬🇧London, United Kingdom
Research Site 4805
🇵🇱Lodz, Poland
Institutul Clinic Fundeni, 4003
🇷🇴Bucuresti, Romania
Clinical Center Zemun 3803
🇷🇸Zemun, Serbia
Cherkassy regional oncology center, 3906
🇺🇦Cherkassy, Ukraine
Hospital Gregorio Maranon, 3405
🇪🇸Madrid, Spain
Research Site 4803
🇵🇱Warszava, Poland
Instytut Hematologii i Transfuzjologii, 4807
🇵🇱Warszawa, Poland
Brasov Country Hospital, 4002
🇷🇴Brasov, Romania
Clinical Center Nis 3802
🇷🇸Nis, Serbia
Research Site 3402
🇪🇸Valencia, Spain
University College, 4401
🇬🇧London, United Kingdom
Research Site 3401
🇪🇸Madrid, Spain
Research Site 4802, 4808
🇵🇱Warszawa, Poland
Saint Petersburg State Institution Of Healthcare, 7001
🇷🇺St. Petersburg, Russian Federation
State Healthcare Institution Tula Regional Clin. Hosp., 7002
🇷🇺Tula, Russian Federation
Clinical center Vojvodina 3801
🇷🇸Novi Sad, Serbia
Reseach Site 3403
🇪🇸Barcelona, Spain
Hospital La Princesa, 3404
🇪🇸Madrid, Spain
Gusak Academy of AMS Ukraine, 3905
🇺🇦Donetsk, Ukraine
St. James's University Hospital, 4403
🇬🇧Leeds, United Kingdom
Khmelnytskyi Regional Hospital, 3903
🇺🇦Khmelnytskyi, Ukraine