Palopegteriparatide for Hypoparathyroidism
(PaTHway60 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of palopegteriparatide, a treatment for adults with hypoparathyroidism, a condition where the body produces too little parathyroid hormone, affecting calcium levels. Participants will receive daily injections of palopegteriparatide, with doses adjusted to find the most effective level. The trial seeks adults who have been on palopegteriparatide at doses of at least 30 mcg/day and still struggle to maintain normal calcium levels. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Is there any evidence suggesting that palopegteriparatide is likely to be safe for humans?
Research has shown that palopegteriparatide, a treatment for hypoparathyroidism, is generally safe. Earlier studies found it to have a good safety record, with most side effects being mild and short-lived. The most common issue was injection site reactions, occurring in more than 5% of patients, but these were not serious.
One study found that about 97% of patients continued with the treatment, indicating it is generally well-tolerated. The FDA has also approved palopegteriparatide for treating hypoparathyroidism, further supporting its safety for this condition. Overall, the treatment appears well-tolerated, with no major safety concerns reported.12345Why do researchers think this study treatment might be promising for hypoparathyroidism?
Researchers are excited about palopegteriparatide for hypoparathyroidism because it offers a novel approach to managing the condition. Unlike traditional treatments that often involve calcium and vitamin D supplements, palopegteriparatide is a subcutaneous injection designed to mimic the body's natural parathyroid hormone. This method not only targets the root cause of hypoparathyroidism more effectively but also allows for better individualized dosing through a new titration algorithm. By potentially improving calcium balance and reducing the burden of frequent monitoring and adjustments, this treatment could significantly enhance the quality of life for patients.
What evidence suggests that palopegteriparatide might be an effective treatment for hypoparathyroidism?
Research has shown that palopegteriparatide may help people with hypoparathyroidism maintain steady calcium levels. One study found that 96% of adults using this treatment stopped their regular therapy after three years. Long-term results indicated its continued effectiveness and safety for up to four years. Patients reported feeling better and experiencing fewer symptoms during treatment. Another study found that 39.3% of participants achieved important health goals by the end of the trial. In this trial, participants will receive palopegteriparatide in either the control arm or the experimental arm, with different titration algorithms being tested. Overall, these findings suggest that palopegteriparatide could be a good option for managing hypoparathyroidism.678910
Who Is on the Research Team?
Medical Director, MD
Principal Investigator
Ascendis Pharma A/S
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous palopegteriparatide daily, titrated to an optimal dose over 78 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Palopegteriparatide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm.
Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascendis Pharma Bone Diseases A/S
Lead Sponsor
Citations
Early U.S. Real-World Treatment Patterns and Outcomes in ...
At the data cut for this analysis, 96.7% of patients remained on palopegteriparatide treatment. Most patients were female (93.5%), younger than 65 years old ( ...
Early U.S. Real-World Treatment Patterns and Outcomes in ...
Mean serum calcium levels remained within the reference range (8.3-10.6 mg/dL) with palopegteriparatide, and no new safety signals were identified with up to 12 ...
Patient-reported outcomes in palopegteriparatide-treated ...
Significant improvements from baseline for all HPES and SF-36v2 measures persisted for more than 2 years after the first exposure to palopegteriparatide, ...
Palopegteriparatide confers benefits for up to 3 years
At 3 years, 96% of adults receiving palopegteriparatide were able to stop receiving conventional therapy.
5.
investors.ascendispharma.com
investors.ascendispharma.com/news-releases/news-release-details/new-4-year-data-shows-sustained-response-transconr-pthNew 4-Year Data Shows Sustained Response to TransCon ...
Long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism.
Safety | YORVIPATH® (palopegteriparatide) HCP Site
Adverse reactions in ≥ 5% of patients with hypoparathyroidism receiving YORVIPATH and with ≥ 2% higher frequency than placebo ... * Injection site reactions ...
216490Orig1s000 - accessdata.fda.gov
The primary safety data for palopegteriparatide in patients with hypoparathyroidism are derived from. Trial TCP-304.12 Supportive safety data ...
Advancing hypoparathyroidism treatment: FDA approval of ...
The treatment also showed a favorable safety profile, with mild transient side effects and no significant toxicity. Unlike standard-of-care ...
Efficacy and safety of palopegteriparatide treatment in ...
Through year 3 of the PaTHway trial, retention rate was high and palopegteriparatide demonstrated consistent longer-term safety and efficacy, which included the ...
10.
checkrare.com
checkrare.com/long-term-safety-and-efficacy-results-of-palopegteriparatide-in-patients-with-hypoparathyroidism/Long-Term Safety and Efficacy Results of ...
Aliya Aziz Khan, MD, discusses long-term safety and efficacy results of palopegteriparatide in patients with hypoparathyroidism.
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