Phase I trial, IQVIA Biotech code: Breye-C22-1005
| ISRCTN | ISRCTN13284995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13284995 |
| IRAS number | 1007664 |
| Secondary identifying numbers | Breye-C22-1005, IRAS 1007664, CPMS 55664 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Phillip Burgess
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
Prescot street
Liverpool
L7 8XP
United Kingdom
| Phone | +44 7 984 530 613 |
|---|---|
| phillip.burgess@liverpoolft.nhs.uk |
Study information
| Study design | Phase I trial in 24 patients |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Dose response |
| 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 | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 02/05/2023 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- Germany
- United Kingdom
Study participating centre
-
-
United Kingdom
United Kingdom
Sponsor information
Breye Therapeutics ApS
Industry
Industry
Agern Allé 24
Hørsholm
2970
Denmark
| info@breye.com | |
| Website | https://breye.com |
Funders
Funder type
Industry
Breye Therapeutics ApS
No information available
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the highly commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results may be posted on or after the date of publication of full trial details. |
| 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. |
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.
