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

NCT ID: NCT07264634

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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 have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.

Conditions

Hypoparathyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Palopegteriparatide

Pregnant women exposed to palopegteriparatide during pregnancy

Palopegteriparatide

Intervention Type: DRUG

Palopegteriparatide prescribed as per normal clinical practice

Interventions

Palopegteriparatide

Palopegteriparatide prescribed as per normal clinical practice

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ascendis Pharma A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, MD

Role: STUDY_DIRECTOR

Ascendis Pharma A/S

Central Contacts

Yorvipath Lactation Inquiries

Role: CONTACT

yorvipathlactation@ubc.com

877-229-2184

Other Identifiers

ASND0044

Identifier Type: -

Identifier Source: org_study_id