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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palopegteriparatide | Pregnant women exposed to palopegteriparatide during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palopegteriparatide | Drug | Palopegteriparatide prescribed as per normal clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the transfer of palopegteriparatide into human breast milk of lactating female participants who are breastfeeding while being treated with YORVIPATH | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible females will be actively recruited from the US participants in the pregnancy registry. Females in the US who want to participate in the lactation study must first enroll in the pregnancy registry and meet the lactation study eligibility criteria study to participate. Females may self enroll into the study or may be enrolled by their healthcare provider (HCP).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yorvipath Lactation Inquiries | Contact | 877-229-2184 | yorvipathlactation@ubc.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascendis Investigational Site | Recruiting | Morgantown | West Virginia | 26508 | United States |
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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