Phase I trial, IQVIA Biotech code: Breye-C22-1005
| ISRCTN | ISRCTN13284995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13284995 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007664 |
| Protocol serial number | Breye-C22-1005, IRAS 1007664, CPMS 55664 |
| Sponsor | Breye Therapeutics ApS |
| Funder | Breye Therapeutics ApS |
- Submission date
- 05/05/2023
- Registration date
- 06/11/2023
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Eye Diseases
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for 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
Public, Scientific, Principal investigator
Prescot street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 7 984 530 613 |
|---|---|
| phillip.burgess@liverpoolft.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I trial in 24 patients |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I trial, IQVIA Biotech code: Breye-C22-1005 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for 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) | Approval pending, ref: 23/NW/0152 |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 | 31/10/2023 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- United Kingdom
- Germany
Study participating centre
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 non-therapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/10/2024: HRA confirmed an extension to the deferral from 18/10/2024 for one year to 18/10/2025.
01/12/2023: Internal review.
05/05/2023: Trial's existence confirmed by NHS HRA.
