Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism

August 10, 2023 updated by: Ascendis Pharma Bone Diseases A/S
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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascendis Pharma Bone Diseases A/S

Collaborators

Clinigen Healthcare Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASNDMAP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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