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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 )

Tracking Information
First Submitted Date December 8, 2022
First Posted Date December 16, 2022
Last Update Posted Date August 14, 2023
 
Descriptive Information
Brief Title Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
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.
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
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: John Caminis, MD +1 844-442-7236 medinfo@ascendispharma.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT05654701
Current Responsible Party Ascendis Pharma A/S ( Ascendis Pharma Bone Diseases A/S )
Original Responsible Party Same as current
Current Study Sponsor Ascendis Pharma Bone Diseases A/S
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Ascendis Pharma A/S
Verification Date August 2023