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TransCon PTH for Hypoparathyroidism (PaTHway Trial)

Phase 3
Waitlist Available
Research Sponsored by Ascendis Pharma Bone Diseases A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of nondominant wrist and hand
Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

PaTHway Trial Summary

This trial is testing a new drug called TransCon PTH to see if it is better than placebo at treating a disease called hypoparathyroidism. The trial will last for 26 weeks, and then participants will be able to continue taking TransCon PTH as part of a long-term extension study.

Who is the study for?
Adults over 18 with hypoparathyroidism who need certain doses of supplements and have stable thyroid-related treatments can join. They must be able to self-inject medication, not have conditions affecting calcium metabolism other than hypoparathyroidism, and agree to contraception if necessary. Excluded are those with PTH-resistance, recent high-risk cancer, seizures, or severe heart issues.Check my eligibility
What is being tested?
The trial tests TransCon PTH against a placebo in adults with hypoparathyroidism. For the first half-year, participants won't know which they're getting as they adjust their dose for optimal effect. Afterward, all get TransCon PTH in a long-term study where doses are tailored individually.See study design
What are the potential side effects?
While specific side effects aren't listed here, common reactions may include irritation at the injection site, potential allergic reactions to ingredients in the medication mix (like metacresol), and changes related to calcium levels due to treatment adjustments.

PaTHway Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My growth plates in my wrist and hand have fully developed, as confirmed by an X-ray.
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I am taking certain medications like calcitriol or calcium supplements.
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My supplements are adjusted to meet specific blood levels.
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My kidney function is adequate.
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I've been taking specific doses of calcitriol, alfacalcidol, or calcium for over 12 weeks.
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I can give myself daily injections or have someone who can.
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I've been taking a specific dose of vitamin D (calcitriol or alfacalcidol) for at least 12 weeks and it's been stable for 5 weeks.
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My thyroid hormone replacement dose has been stable for over 5 weeks.
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I have had low calcium due to low parathyroid hormone levels for at least 6 months.
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I am 18 years old or older.

PaTHway Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - Primary endpoint
Secondary outcome measures
Change from baseline in HPES Impact - Daily Life Domain score
Change from baseline in HPES Impact - Physical Functioning Domain score
Change from baseline in HPES Symptom - Cognitive Domain score
+2 more

PaTHway Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TransCon PTHExperimental Treatment1 Intervention
TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Placebo for TransCon PTH delivered once daily by subcutaneous injection

Find a Location

Who is running the clinical trial?

Ascendis Pharma Bone Diseases A/SLead Sponsor
1 Previous Clinical Trials
1 Trials studying Hypoparathyroidism
Aimee D Shu, MDStudy DirectorAscendis Pharma A/S North American Medical Monitor/Medical Expert
3 Previous Clinical Trials
606 Total Patients Enrolled
Michael Beckert, MDStudy DirectorAscendis Pharma A/S European Medical Monitor/Medical Expert
7 Previous Clinical Trials
657 Total Patients Enrolled
1 Trials studying Hypoparathyroidism
59 Patients Enrolled for Hypoparathyroidism

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04701203 — Phase 3
Hypoparathyroidism Research Study Groups: TransCon PTH, Placebo
Hypoparathyroidism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04701203 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04701203 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are institutions in the US participating in this research?

"Currently, the study is being conducted in 15 different centres, with at least one location in each of Halifax, Reno and Rochester. To reduce time commitment, it is recommended that patients select the site nearest to them."

Answered by AI

Has the TransCon PTH medical treatment received regulatory approval from the FDA?

"TransCon PTH has been studied in multiple Phase 3 trials, meaning there is some data to support both its efficacy and safety. Our team rates its safety as a 3."

Answered by AI
~20 spots leftby Mar 2025