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

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: EUCTR2020-002726-84-GB
• Lead Sponsor: Premacure AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-11
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 382

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: 382
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 follow-up as determined by the investigator.

Study & Design

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