A study evaluating the safety and efficacy of an experimental drug forchronic lung disease against normally prescribed care in extremelypremature babies

Phase 1

• Conditions: Chronic Lung Disease; MedDRA version: 21.1Level: LLTClassification code 10066204Term: Chronic lung disease of prematuritySystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001393-16-IT
• Lead Sponsor: PREMACURE AB, A MEMBER OF SHIRE GROUP OF COMPANIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Written informed consents and/or assents must be signed and dated
by the subject's parent(s) or legally authorized representative(s), if
applicable, prior to any study-related procedures. The informed consent
and any assents for underage parents must be approved by the
institutional review board (IRB)/independent ethics committee (IEC).
2. Written informed consents and/or assents must be signed and dated
by the subject's birth mother or her legally authorized representative(s),
if applicable, prior to providing study-related information related to birth
mother medical history, pregnancy and the birth of the subject. The
informed consent and any assents for underage birth mothers must be
approved by the IRB/IEC.
XML File Identifier: elrCJttlaCTVeNuyT5tKPfNNMns=
Page 11/25
3. Initially, subjects must be between GA of 26 weeks +0 days and 27
weeks +6 days, inclusive. After approximately 75 subjects
(approximately 25 subjects in each treatment group) have completed
the PMA 40 weeks visit, an independent DMC will assess safety data and
may authorize enrollment of subjects of GA between 23 weeks +0 days
and 27 weeks +6 days, inclusive.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Detectable major (or severe) congenital malformation identified
before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or
syndrome, identified before randomization, according to the
investigator's opinion.
3. Hypoglycemia at Baseline (blood glucose <45 mg/dL or 2.5 mmol/L)
which persists in spite of glucose supplementation, to exclude severe
congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before
randomization according to cranial ultrasound (hemorrhages confined to
the germinal matrix are allowed) and
investigator's opinion.
5. Any other condition or therapy that, in the investigator's opinion, may
pose a risk to the subject or interfere with the subject's potential
compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another
investigational study drug, device, or procedure (participation in
observational studies is permitted on a case-by-case basis).
7. The subject or subject's parent(s) or legally authorized
representative(s) is/are unable to comply with the protocol or is unlikely
to be available for long-term follow-up as determined by the
investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified