Phase II study. The Newcastle upon Tyne Hospitals NHS Foundation Trust code: 09422
| ISRCTN | ISRCTN98936300 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98936300 |
| EudraCT/CTIS number | 2020-004958-30 |
| IRAS number | 1004317 |
| Secondary identifying numbers | IRAS 1004317; The Newcastle upon Tyne Hospitals NHS Foundation Trust code: 09422; CPMS 51903 |
- 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
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 when the results are published, which will be within 30 months after the trial has ended.
Contact information
Prof David Jones
Principal Investigator
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 |
Mrs Irena Bibby
Public
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
| Study design | Single centre interventional double-blind phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | |
| 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 | 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. |
| 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 when the results are published, which will be within 30 months after the trial has ended. |
| Overall study start date | 17/01/2022 |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Level 1 Regent Point
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 1912824461 |
|---|---|
| tnu-tr.sponsormanagement@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Industry
Intercept Pharmaceuticals
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Intercept, Intercept Pharma, Intercept Pharmaceuticals, Inc., Intercept Pharmaceuticals Inc
- Location
- United States of America
Results and Publications
| Intention to publish date | 28/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Trial information and summary results 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 II study and the negligible benefit to the public of phase II information. |
| 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 |
Editorial Notes
05/05/2022: Internal review.
28/04/2022: Trial's existence confirmed by NHS HRA.
