Phase Ib Trial: 273391
| ISRCTN | ISRCTN93130126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93130126 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2023-507340-36-00 |
| Integrated Research Application System (IRAS) | 1009618 |
| Protocol serial number | IRAS 1009618 |
| Sponsor | Enthera S.r.l. |
| Funder | Enthera S.r.l. |
- Submission date
- 12/04/2024
- Registration date
- 12/04/2024
- Last edited
- 30/10/2024
- 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
Principal investigator
Parexel Early Phase Clinical Unit - Northwick Park Hospital
Level 7 Watford Road
Harrow
London
HA1 £UJ
United Kingdom
| Phone | +44 (0)1895614973 |
|---|---|
| david.steel@parexel.com |
Scientific
Via Visconti di Modrone Uberto 18
Milan
20122
Italy
| Phone | +39 (0)3456306238 |
|---|---|
| filippo.canducci@entherapharmaceuticals.com |
Public
Via Visconti di Modrone Uberto 18
milan
20122
Italy
| Phone | +39 (0)249533580 |
|---|---|
| raffaella.maucci@entherapharmaceuticals.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Safety, tolerability, and pharmacokinetics study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase Ib Trial: 273391 |
| 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 02/04/2024, London - Riverside REC (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)2071048150; riverside.rec@hra.nhs.uk), ref: 24/LO/0180 |
| 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 | 10/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 55 |
| 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 | 03/04/2024 |
| Date of final enrolment | 03/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Bulgaria
- Georgia
- Hungary
- Moldova
- Netherlands
- Romania
Study participating centre
Level 7, Watford Road
Harrow
HA1 3UJ
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
30/10/2024: Contact and sponsor details updated.
09/05/2024: Contact details updated.
13/02/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
