ong-Term follow up study after administration of SHP607 in ExtremelyPremature Infants

Phase 1

• Conditions: Chronic Lung Disease; MedDRA version: 21.1Level: PTClassification code 10025082Term: Lung disorderSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002726-84-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: 2021-05-24
• Study Completion: 2022-10-11
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.Subject was randomized into Study SHP607-202. Subjects who were
randomized, but did not complete Study SHP607-202 must be at least 12
months CA.
2.Written informed consents (and assents, if applicable) must be signed
and dated by the subject's parent(s)/legally authorized
representative(s) 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).
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

Subjects are excluded from the study if the subject or subject's
parent(s)/legally authorized representative(s) is/are unable to comply
with the protocol or is/are unlikely to be available for long-term followup as determined by the investigator.

Study & Design

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