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CFTR Modulators in Pregnancy and Postpartum

NCT ID: NCT06302270

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2039-01-31

Brief Summary

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Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mother-infant dyads

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

Exclusion Criteria

none
Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stockholm CF center

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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jenny svedenkrans

Role: CONTACT

[email protected]
+46 8 123 80000

Terezia Pinzikova

Role: CONTACT

+46 8 123 80000

Facility Contacts

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Terezia Pinzikova, MD, PhD

Role: primary

[email protected]
+46 8 123 80000

Other Identifiers

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K2024-0507

Identifier Type: -

Identifier Source: org_study_id

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