Status:
RECRUITING
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
Lead Sponsor:
Ascendis Pharma A/S
Conditions:
Hypoparathyroidism
Eligibility:
FEMALE
18-50 years
Brief Summary
This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who ...
Eligibility Criteria
Inclusion Criteria:
- 1. Lactating female participants 18 years of age or older treated with YORVIPATH as part of their usual medical care and who have chosen to breastfeed. Note: The participant must have been taking YORVIPATH for a minimum of 14 days prior to sample collection.
- 2. The major source of infant nutrition must be breast milk (Note: Only one supplemental bottle of no more than up to 8 oz of formula per day will be allowed during the 14 days before start of the study).
- 3. Daily dose of YORVIPATH administered within the last 14 days has been stable.
- 4. Participants recruited from other sources must enroll in the Pregnancy Registry before being allowed to participate in the Lactation Study.
- 5. Written consent or eConsent obtained.
Exclusion Criteria:
- 1. Presence of any medical condition that, in the opinion of the investigator, may impair the ability to breastfeed during this study, including but not limited to mastitis and nipple malformation
Key Trial Info
Start Date :
March 19 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07264634
Start Date
March 19 2026
End Date
January 1 2028
Last Update
April 17 2026
Active Locations (1)
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1
Ascendis Investigational Site
Morgantown, West Virginia, United States, 26508