Phase I Trial: 323476
| ISRCTN | ISRCTN16585188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16585188 |
| IRAS number | 323476 |
| Secondary identifying numbers | IRAS 323476, CPMS 59146 |
- Submission date
- 10/09/2024
- Registration date
- 13/09/2024
- Last edited
- 13/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Prof Amanda Adler
Scientific, Principal Investigator
Scientific, Principal Investigator
University of Oxford, Diabetes Trial Unit
Oxford
OX3 7LJ
United Kingdom
| enquiries@rdm.ox.ac.uk |
Dr Information Team
Public
Public
117 Charterhouse Street
London
EC1M 6AA
United Kingdom
| info@sava.health |
Study information
| Study design | Multi-site trial with 50 participants |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | 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) |
Approved 22/03/2024, London - Dulwich Research Ethics Committee (2nd Floor, 2 Redman Place, London, E20 1JO, United Kingdom; 0207 104 8290; dulwich.rec@hra.nhs.uk), ref: 24/LO/0134 |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/06/2023 |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 50 |
| 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 | 20/09/2024 |
| Date of final enrolment | 01/04/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital Laboratory
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
SAVA Technologies Ltd.
Industry
Industry
117 Charterhouse Street
London
EC1M 6AA
England
United Kingdom
| info@sava.health |
Funders
Funder type
Industry
SAVA Technologies Ltd.
No information available
Results and Publications
| Intention to publish date | 03/08/2027 |
|---|---|
| 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 high 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
10/09/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
