Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
55
Countries
3
Sites
15
Primary immune thrombocytopenia (ITP)
Key facts
- Sponsor
- Hutchmed Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 24 Jul 2024 → 19 May 2025
- Decision date (initial)
- 2024-08-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary immune thrombocytopenia (ITP)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10083843 | Primary immune thrombocytopenia | 10005329 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hutchmed Ltd.
- Sponsor organisation
- Hutchmed Ltd.
- Address
- Building 4, 720 Cailun Road, China (Shanghai) Pilot Free Trade Zone 720 Cailun Road China (Shanghai) Pilot Free Trade Zone
- City
- Shanghai
- Postcode
- 201203
- Country
- China
Scientific contact point
- Organisation
- Hutchmed Ltd.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Hutchmed Ltd.
- Contact name
- Clinical Trial Information
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 7 | 4 |
| Norway | Ended | 3 | 2 |
| Spain | Ended | 12 | 9 |
| Rest of world
Australia, United States
|
— | 33 | — |
Investigational sites
Universitaetsmedizin Goettingen
Department of Hematology and Medical Oncology, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Schleswig-Holstein AöR
Klinik for Hematology and Oncology, Ratzeburger Allee 160, 23538, Luebeck
Charite Universitaetsmedizin Berlin KöR
Department of Hematology, Oncology and Tumorimmunology, Hindenburgdamm 30, Lichterfelde, Berlin
Marien Hospital Duesseldorf GmbH
Klinik für Onkologie, Hämatologie und Palliativmedizin, Rochusstrasse 2, Pempelfort, Duesseldorf
Ostfold Hospital Trust
Department of Research, P. O. Box 16, 1603, Fredrikstad
Oslo University Hospital HF
Department of Haematology, Sognsvannsveien 20, 0372, Oslo
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario De Burgos
Hematology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Del Mar
Hematology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital General Universitario Morales Meseguer
Hematology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario Infanta Leonor
Hematology, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2024-08-08 | ||||
| Spain | 2024-07-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-01 | Norway | Acceptable 2024-06-03
|
2024-06-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Norway | Acceptable | 2024-06-25 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-06-14 | Acceptable 2024-06-03
|
2024-08-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-18 | Norway | Acceptable 2025-01-15
|
2025-01-15 |