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Study on the Safety and Effectiveness of TransCon PTH for Adults with Hypoparathyroidism

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What is this study about?

This clinical trial is focused on studying a condition called hypoparathyroidism in adults. Hypoparathyroidism is a disorder where the body produces insufficient amounts of parathyroid hormone, leading to low levels of calcium in the blood. The treatment being investigated in this study is called TransCon PTH, which is a solution for injection administered daily using a pre-filled pen. TransCon PTH contains an active substance known as palopegteriparatide, which is designed to help manage calcium levels in the body.

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of TransCon PTH in adults with hypoparathyroidism. Participants in the study will receive either TransCon PTH or a placebo. The study will begin with a period where participants are randomly assigned to receive either the treatment or placebo without knowing which one they are receiving. This is followed by an open-label extension, where all participants will have the opportunity to receive TransCon PTH. The study will monitor changes in calcium levels in the blood and urine, as well as the need for additional vitamin D and calcium supplements over a period of four weeks.

Throughout the study, participants will be required to perform daily injections of the study drug. The trial aims to determine if TransCon PTH can help maintain normal calcium levels without the need for additional supplements. The study will also assess the overall experience of using the treatment, including any side effects that may occur. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 joining the study

Upon joining the study, the participant will be required to provide written, signed consent.

Eligibility is confirmed based on criteria such as age, medical history, and current health status.

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s current health status.

This includes checking levels of calcium, vitamin D, and other relevant health markers.

3 randomization and treatment

Participants will be randomly assigned to receive either the study drug TransCon PTH or a placebo.

The study drug is administered as a daily subcutaneous injection using a pre-filled pen.

4 treatment phase

The treatment phase lasts for 4 weeks, during which the participant will continue daily injections.

Participants will be monitored for changes in calcium and vitamin D levels, as well as any side effects.

5 evaluation of primary endpoints

At the end of 4 weeks, the primary endpoints will be evaluated.

These include maintaining normal calcium levels without the need for additional vitamin D supplements and reducing calcium supplement intake.

6 open-label extension

Participants may enter an open-label extension phase where all receive the study drug.

This phase allows for continued monitoring and assessment of long-term effects.

Who Can Join the Study?

  • Men and women who are 18 years or older can participate.
  • Participants must be able to give themselves a daily injection under the skin using a pre-filled pen, or have someone else do it for them.
  • Participants need to provide a written and signed agreement to join the study.
  • Participants should have chronic hypoparathyroidism (HP), which means low calcium levels in the blood due to low levels of a hormone called parathyroid hormone (PTH). This condition should be present for at least 26 weeks and can be due to surgery, autoimmune issues, genetic reasons, or unknown causes.
  • Participants must be on a stable dose of certain medications for at least 12 weeks before the study starts. These medications include active vitamin D (like calcitriol or alfacalcidol) and calcium supplements (like calcium citrate or carbonate). If they have had high calcium levels in the past, they might be on lower doses with special approval.
  • Participants need to adjust their supplements before the study to reach target levels of vitamin D, magnesium, and calcium in the blood. If they have trouble maintaining normal magnesium levels, a slightly lower level might be acceptable with special approval.
  • Participants should have a Body Mass Index (BMI) between 17 and 40 kg/m² at the first visit. BMI is a measure of body fat based on height and weight.
  • If participants are 25 years old or younger, they need to show that their bones have finished growing, which is checked by an x-ray of the wrist and hand.
  • Participants should have a kidney function test result (eGFR) greater than 30 mL/min/1.73m² during the screening. eGFR is a test that shows how well the kidneys are working.
  • The level of thyroid-stimulating hormone (TSH) in the blood should be within normal limits in the 12 weeks before the first visit. If they are on treatment for thyroid cancer, the TSH level should be at least 0.2 µIU/mL.
  • If participants are taking thyroid hormone replacement therapy, the dose should be stable for at least 12 weeks before the first visit.

Who Cannot Join the Study?

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not have Hypoparathyroidism (HP) cannot participate. This is a condition where the body produces too little parathyroid hormone, which helps control calcium levels in the blood.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Rigshospitalet Copenhagen Denmark
Universita’ Campus Bio-medico Di Roma Rome Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Slpsjabcsuzrqpdbzi Phqtdqmpgip Phco Oslo Norway
Aopjkhm Uvfew Sxybzozxq Lopcms Dm Basgqic Bologna Italy
Agkwof Uvzvhnyufs Hrlqkgrv Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.10.2019
Germany Germany
Not recruiting
01.10.2019
Italy Italy
Not recruiting
01.10.2019
Norway Norway
Not recruiting
01.10.2019

Trial locations

Investigated drugs:

TransCon PTH is a medication being studied for its potential to help adults with hypoparathyroidism. This condition affects the levels of calcium in the body. TransCon PTH is given as a daily injection under the skin. The trial aims to see how well this medication can manage calcium levels in the blood and urine, and how it might reduce the need for other treatments like active vitamin D and calcium supplements.

Investigated diseases:

Hypoparathyroidism – Hypoparathyroidism is a condition where the parathyroid glands produce insufficient amounts of parathyroid hormone. This hormone is crucial for regulating and maintaining a balance of calcium and phosphorus in the body. When levels are low, it can lead to low calcium levels in the blood and increased phosphorus levels. Symptoms may include muscle cramps, tingling in the fingers, and fatigue. Over time, the condition can affect the health of bones, teeth, and muscles. It is a rare disease that primarily affects adults.

Trial ID:
2024-512967-29-00
Protocol code:
TransCon PTH TCP-201
Trial Phase:
Therapeutic exploratory (Phase II)

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