Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
2
Sites
5
Paroxysmal nocturnal hemoglobinuria
Key facts
- Sponsor
- Omeros Ireland Limited, Omeros Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 May 2023 → 11 Oct 2024
- Decision date (initial)
- 2022-11-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-501190-39-01
- ISRCTN
- ISRCTN71522737
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Paroxysmal nocturnal hemoglobinuria
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Omeros Ireland Limited
- Sponsor organisation
- Omeros Ireland Limited
- Address
- Ormond Building, 31-36 Ormond Quay Upper 31-36 Ormond Quay Upper
- City
- Dublin 7
- Postcode
- D07 EE37
- Country
- Ireland
Scientific contact point
- Organisation
- Omeros Ireland Limited
- Contact name
- William Pullman
Public contact point
- Organisation
- Omeros Ireland Limited
- Contact name
- Clinical Trial Administrator
Omeros Corp.
- Sponsor organisation
- Omeros Corp.
- Address
- 201 Elliott Avenue West
- City
- Seattle
- Postcode
- 98119-4265
- Country
- United States
Scientific contact point
- Organisation
- Omeros Corp.
- Contact name
- William Pullman
Public contact point
- Organisation
- Omeros Corp.
- Contact name
- Clinical Trial Administrator
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 4 | 3 |
| Greece | Ended | 1 | 2 |
| Rest of world
Switzerland, United Kingdom
|
— | 9 | — |
Investigational sites
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Institut für Klinische Transfusionsmedizin und Immungenetik Ulm (IKT), Helmholtzstrasse 10, Eselsberg, Ulm
Universitaetsklinikum Aachen AöR
KlinikfirHämatologie Onkologie, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik 1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Geniko Nosokomeio Thessalonikis George Papanikolaou
Hematology, Exochi, 570 10, Thessaloniki
University Of Patras
THE BONE MARROW TRANSPLANTATION UNIT, University Hospital of Patras, BMT Unit, Rio / Patras
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 |
|---|---|---|---|---|---|
| Germany | 2023-06-07 | 2024-10-10 | 2023-08-21 | 2023-11-15 | |
| Greece | 2023-05-15 | 2024-02-13 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-03 | Germany | Acceptable with conditions 2022-11-10
|
2022-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-12-22 | Germany | Acceptable 2023-03-20
|
2023-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-04-27 | Germany | Acceptable 2023-07-31
|
2023-08-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-06 | Germany | Acceptable 2024-06-04
|
2024-06-10 |