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A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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 have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
West Virginia
Ascendis Investigational Site
RECRUITING
Morgantown
Contact Information
Primary
Yorvipath Lactation Inquiries
yorvipathlactation@ubc.com
877-229-2184
Time Frame
Start Date: 2026-03-19
Estimated Completion Date: 2028-01
Participants
Target number of participants: 10
Treatments
Palopegteriparatide
Pregnant women exposed to palopegteriparatide during pregnancy
Related Therapeutic Areas
Sponsors
Leads: Ascendis Pharma A/S

This content was sourced from clinicaltrials.gov

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