Phase II study. The Newcastle upon Tyne Hospitals NHS Foundation Trust code: 09422
| ISRCTN | ISRCTN98936300 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98936300 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2020-004958-30 |
| Integrated Research Application System (IRAS) | 1004317 |
| Protocol serial number | IRAS 1004317; The Newcastle upon Tyne Hospitals NHS Foundation Trust code: 09422; CPMS 51903 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | Intercept Pharmaceuticals |
- Submission date
- 27/04/2022
- Registration date
- 28/04/2022
- Last edited
- 05/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
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 when the results are published, which will be within 30 months after the trial has ended.
Contact information
Principal investigator
Institute of Cellular Medicine
4th Floor William Leech Building
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 1912087572 |
|---|---|
| david.jones@ncl.ac.uk |
Public
Newcastle Clinical Trials Unit
1–4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 1912082526 |
|---|---|
| oacstrials@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional double-blind phase II trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase II study. The Newcastle upon Tyne Hospitals NHS Foundation Trust code: 09422 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 when the results are published, which will be within 30 months after the trial has ended. |
| 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 when the results are published, which will be within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 08/03/2022, London - Hampstead Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 207 104 8345; hampstead.rec@hra.nhs.uk), ref: 22/LO/0115 2. Approved 09/03/2022, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU; +44 20 3080 6000; info@mhra.gov.uk), ref: CTA 17136/0298/001-0001 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 when the results are published, which will be 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 when the results are published, which will be within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase II |
| 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 when the results are published, which will be 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 when the results are published, which will be 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 when the results are published, which will be within 30 months after the trial has ended. |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 25 |
| 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 when the results are published, which will be 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 when the results are published, which will be within 30 months after the trial has ended. |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | Data sharing statement to be made available at a later date . |
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
05/05/2022: Internal review.
28/04/2022: Trial's existence confirmed by NHS HRA.
