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Trial · Expanded access

Approved for marketingPhase not statedRegistry data

Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

NCTNCT05654701 (opens ClinicalTrials.gov in a new tab)Other idASNDMAP001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Approved for marketing
Phase
Phase not stated
Enrollment
Not stated
Sponsor
Ascendis Pharma Bone Diseases A/S · Industry
Design
Not stated
Countries
Not stated
Start
Not stated
Primary completion
Not stated
Completion
Not stated
First posted
16 Dec 2022
Last update posted
27 Jun 2025
Conditions
Hypoparathyroidism

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Palopegteriparatide (TransCon PTH)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
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.

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