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NCT06302270 Clinical Trial

CFTR Modulators in Pregnancy and Postpartum

Cystic Fibrosis Clinical Trial

Official title:
Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06302270
Other study ID # K2024-0507
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2024
Est. completion date January 31, 2039

Study information
Verified date March 2024
Source Region Stockholm
Contact jenny svedenkrans
Phone +46 8 123 80000
Email jenny.svedenkrans@regionstockholm.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date January 31, 2039
Est. primary completion date January 31, 2034
Accepts healthy volunteers No
Gender All
Age group N/A to 50 Years
Eligibility Inclusion Criteria: Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman Exclusion Criteria: none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Stockholm CF center Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Region Stockholm Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health effects in the newborn infant 6 years
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