Phase I trial - 2021-006930-37

ISRCTN	ISRCTN15751828
DOI	https://doi.org/10.1186/ISRCTN15751828
EudraCT/CTIS number	2021-006930-37
IRAS number	1004695
Secondary identifying numbers	IRAS 1004695, CPMS 52873

Submission date: 15/07/2022
Registration date: 15/07/2022
Last edited: 01/11/2022

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

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

Dr Katie Neville
Scientific

Bionical Emas
Findern Lane
The Piazza Mercia Marina
Willington
Derby
DE65 6DW
United Kingdom

Phone	+44 1462 424400
Email	RegulatoryClinDev@bionical-emas.com

Dr Morag Griffin
Principal Investigator

St James University Hospital
Leeds
LS9 7TF
United Kingdom

Phone	+44 (0)113 206 8513
Email	m.griffin@nhs.net

Study information

Study design	Interventional open-label phase I study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format
Scientific title	Phase I trial - 2021-006930-37 [The full scientific title will be published within 30 months after the end of the trial]
Study hypothesis	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)	1. Approved 16/06/2022, London -Chelsea Research Ethics Committee (2 Redman Place, Stratford, London E20 1JQ, UK: +44(0)207 1048064; chelsea.rec@hra.nhs.uk), ref: 22/LO/0352 2. Approved 17/06/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; ( +44 (0)20 3080 6000; info@mhra.gov.uk); ref: CTA 49709/0003/001-0001 The HRA has approved deferral of publication of trial details.
Condition	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)
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	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	19/04/2022
Overall study end date	12/04/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	12
Participant 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
Participant 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
Recruitment start date	30/08/2022
Recruitment end date	30/06/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St. James' University Hospital

Beckett Street
Leeds
LS9 7T
United Kingdom

Sponsor information

Omeros Corporation (United States)
Industry

Waterfront Research Center
201 Elliott Ave
Seattle
WA 98119
United States of America

Phone	+1 844 663 7671
Email	smagazu@omeros.com
Website	http://www.omeros.com/
"ROR"	https://ror.org/01r5k6556

Funders

Funder type

Industry

Omeros Corporation
Government organisation / For-profit companies (industry)

Alternative name(s): Omeros, Omeros Corp, OMS
Location: United States of America

Results and Publications

Intention to publish date	01/10/2027
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 will 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 nontherapeutic clinical trials.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

01/11/2022: The scientific contact details were changed.
04/08/2022: Internal review.
15/07/2022: Trial's existence confirmed by the HRA.