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Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

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ClinicalTrials.gov Identifier: NCT05654701
Expanded Access Status : Available
First Posted : December 16, 2022
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Ascendis Pharma A/S ( Ascendis Pharma Bone Diseases A/S )

Study Description
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Brief Summary:
To provide palopegteriparatide (TransCon PTH), an investigational parathyroid hormone (PTH) replacement therapy in an expanded access setting for adult patients with hypoparathyroidism who have previously received PTH-treatment, who meet the eligibility criteria for this protocol as described below and have a clear unmet medical need that cannot be adequately treated by a commercial product or a clinical trial.

Condition or disease Intervention/treatment
Hypoparathyroidism Drug: Palopegteriparatide (TransCon PTH)

Detailed Description:

This is an expanded access program for eligible participants who previously received PTH treatment and who are ineligible for an ongoing TransCon PTH clinical trial. The treating physician/investigator contacts Ascendis Pharma when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Participants will start with a fixed dose of study drug and will be individually and progressively titrated to an optimal dose based on serum calcium levels, followed by an individualized dosing period until palopegteriparatide is commercially available to the participant. For patients taking conventional therapy with calcium and or active forms of vitamin D, these therapies will be reduced in dose and/or discontinued during titration of palopegteriparatide.

Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Palopegteriparatide (TransCon PTH)
    The investigational drug Palopegteriparatide (TransCon PTH) is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosis of hypoparathyroidism.
  • Patients with previous PTH-treatment experience.
  • Serum albumin-adjusted calcium level ≥7.8 mg/dL and 25(OH) vitamin D in the normal range within 2 weeks before first dose.
  • Body mass index (BMI) 17 - 40 kg/m2.
  • Be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form (ICF).

Exclusion Criteria:

  • Diagnosis of pseudohypoparathyroidism.
  • Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
  • Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2).
  • Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton
  • Active malignancy within past 2 years excluding successfully resected thyroid carcinoma and non-melanoma skin cancer.
  • Severe or decompensated cardiac disease within 26 weeks, including but not limited to class IV or Stage D heart failure, unstable angina, myocardial infarction or uncontrolled arrhythmias.
  • Pregnant or lactating females, or females intending to become pregnant.
  • Known allergy and/or sensitivity to palopegteriparatide or its excipients or prior PTH therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05654701


Contacts
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Contact: John Caminis, MD +1 844-442-7236 medinfo@ascendispharma.com

Sponsors and Collaborators
Ascendis Pharma Bone Diseases A/S
More Information
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Responsible Party: Ascendis Pharma Bone Diseases A/S
ClinicalTrials.gov Identifier: NCT05654701    
Other Study ID Numbers: ASNDMAP001
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Keywords provided by Ascendis Pharma A/S ( Ascendis Pharma Bone Diseases A/S ):
Hypoparathyroidism
Parathyroid Hormone
TransCon PTH
PTH(1-34)
Expanded Access
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases