Phase I trial - 2021-006930-37
| ISRCTN | ISRCTN15751828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15751828 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021-006930-37 |
| Integrated Research Application System (IRAS) | 1004695 |
| Protocol serial number | IRAS 1004695, CPMS 52873 |
| Sponsor | Omeros Corporation (United States) |
| Funder | Omeros Corporation |
- Submission date
- 15/07/2022
- Registration date
- 15/07/2022
- Last edited
- 03/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended
Contact information
Scientific
Omeros Corporation
Waterfront Research Center
201 Elliott Ave
Seattle
WA 98119
United States of America
| Phone | +1 844 663 7671 |
|---|---|
| smagazu@omeros.com |
Principal investigator
St James University Hospital
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 206 8513 |
|---|---|
| m.griffin@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional open-label phase I study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I trial - 2021-006930-37 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Ethics approval(s) | 1. Approved 16/06/2022, London -Chelsea Research Ethics Committee (2 Redman Place, Stratford, London E20 1JQ, UK: +44(0)207 1048064; chelsea.rec@hra.nhs.uk), ref: 22/LO/0352 2. Approved 17/06/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; ( +44 (0)20 3080 6000; info@mhra.gov.uk); ref: CTA 49709/0003/001-0001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Primary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Key secondary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Completion date | 12/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 12 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Date of first enrolment | 30/08/2022 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds
LS9 7T
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of nontherapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/10/2025: A study contact was changed.
01/11/2022: The scientific contact details were changed.
04/08/2022: Internal review.
15/07/2022: Trial's existence confirmed by the HRA.
