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

Purpose

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.

Condition

  • Hypoparathyroidism

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Palopegteriparatide Pregnant women exposed to palopegteriparatide during pregnancy
  • Drug: Palopegteriparatide
    Palopegteriparatide prescribed as per normal clinical practice

Recruiting Locations

Ascendis Investigational Site
Morgantown, West Virginia 26508

More Details

Status
Recruiting
Sponsor
Ascendis Pharma A/S

Study Contact

Yorvipath Lactation Inquiries
877-229-2184
yorvipathlactation@ubc.com