Clinical trial • Phase III • Neurology

CHF6467 for Neonatal hypoxic-ischemic encephalopathy (HIE)

Phase III trial of CHF6467 for Neonatal hypoxic-ischemic encephalopathy (HIE). 68 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Neonatal hypoxic-ischemic encephalopathy (HIE)
Trial Stage
Phase III
Drug Modality
Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
15-05-2025
First CTIS Authorization Date
05-08-2025

Trial design

Phase III trial across 2 sites in Bulgaria.

Target Sample Size
68
Trial Duration For Participant
379

Eligibility

Recruits 68 paediatric patients.

Vulnerable Population
Vulnerable population selected: Neonates (Neonatal Hypoxic-Ischemic Encephalopathy). No consent/assent information provided in the record.

Recruitment

Planned Sample Size
68
Recruitment Window Months
12
Consent Approach
No information provided on informed consent or assent process; vulnerable participants (neonates) are indicated in the record.

Geography

Total Number Of Sites
2
Total Number Of Participants
68

Bulgaria

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
218
Number Of Sites
2
Number Of Participants
68

Sites

Site Name
Medical Center Comac Medical Ltd.
Contact Person Name
Maya Dabcheva
Site Name
Medical Center Comac Medical Ltd.
Contact Person Name
Maya Dabcheva

Sponsor

Primary sponsor

Full Name
Chiesi Farmaceutici S.p.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
CHF6467
Modality
Other
Routes Of Administration
Intranasal
Route
Intranasal

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