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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
eGFR ≥30 mL/min/1.73 m2 during Screening
Must not have
High risk thyroid cancer within 2 years, requiring suppression of TSH <0.2 mIU/mL
Disease processes that adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, significant small bowel resection, gastric bypass, tropical sprue, active celiac disease, active ulcerative colitis, active Crohn's disease, gastroparesis and AIRE gene mutations with malabsorption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My growth plates in my wrist and hand have fully developed, as confirmed by an X-ray.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My thyroid cancer is high risk and I need treatment to lower my TSH below 0.2.
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I do not have conditions that affect my body's ability to absorb nutrients.
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I have not had a stroke in the last 5 years.
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I am not taking specific medications like loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids (unless it's for replacement therapy).
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I haven't used any osteoporosis treatments affecting calcium or bone in the last 2 years.
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My female partner might become pregnant and we are not planning to use birth control during the trial.
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I have a condition where my body doesn't respond to PTH hormone, leading to low calcium.
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I am allergic to PTH or ingredients in its medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy - Primary endpoint
Secondary study objectives
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious heart issues like heart failure or a heart attack in the last 6 months.My thyroid cancer is high risk and I need treatment to lower my TSH below 0.2.My growth plates in my wrist and hand have fully developed, as confirmed by an X-ray.I had a kidney stone or gout attack within the last 6 months, but I can join if I only have kidney stones without symptoms.I am taking certain medications like calcitriol or calcium supplements.I have not taken water pills in the last 4 weeks.I do not have conditions that affect my body's ability to absorb nutrients.My supplements are adjusted to meet specific blood levels.My kidney function is adequate.I have not had a stroke in the last 5 years.I've been taking specific doses of calcitriol, alfacalcidol, or calcium for over 12 weeks.I can give myself daily injections or have someone who can.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.I am not taking specific medications like loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids (unless it's for replacement therapy).I haven't used any PTH-like drugs in the last 4 weeks.I haven't used any osteoporosis treatments affecting calcium or bone in the last 2 years.My female partner might become pregnant and we are not planning to use birth control during the trial.My thyroid hormone replacement dose has been stable for over 5 weeks.I am at high risk for bone cancer due to Paget's disease, high alkaline phosphatase levels, genetic conditions, or previous significant radiation therapy to my bones.I do not have any conditions that affect my calcium or hormone levels.I have a seizure disorder and had a seizure in the last 6 months.I don't have any health issues that could stop me from completing the trial or pose a risk.I have had low calcium due to low parathyroid hormone levels for at least 6 months.I have a condition where my body doesn't respond to PTH hormone, leading to low calcium.I am 18 years old or older.You have been diagnosed with a drug or alcohol addiction within the past 3 years.I haven't taken drugs affecting bone metabolism in the last 12 weeks.I am allergic to PTH or ingredients in its medication.
Research Study Groups:
This trial has the following groups:- Group 1: TransCon PTH
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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