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TransCon PTH for Hypoparathyroidism (PaTHway Trial)
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.
PaTHway Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPaTHway Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PaTHway Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: TransCon PTH
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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