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Hormone Therapy
TransCon PTH for Hypoparathyroidism (PaTH Forward Trial)
Phase 2
Waitlist Available
Research Sponsored by Ascendis Pharma A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
eGFR >30 mL/min/1.73m2 during Screening
If ≤25 years of age, radiological evidence of epiphyseal closure based on x-ray of non-dominant wrist and hand
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
PaTH Forward Trial Summary
This trial is testing a new medication, TransCon PTH, to see if it is effective and safe for people with a certain medical condition. The trial will last for four weeks, during which participants will be given either TransCon PTH or a placebo. After the four weeks, all participants will receive TransCon PTH.
Who is the study for?
Adults over 18 with chronic hypoparathyroidism (HP) for at least half a year, taking specific vitamin D and calcium supplements, can join this trial. They must be able to self-inject medication and not have certain genetic mutations or recent use of related drugs. Pregnant women, those with severe heart or kidney issues, drug/alcohol dependence, or other conditions affecting calcium metabolism are excluded.Check my eligibility
What is being tested?
The trial is testing TransCon PTH against a placebo in adults with HP. Initially, participants are randomly assigned to receive either the drug or placebo via injection without knowing which one they're getting. After four weeks, all move on to receive TransCon PTH tailored to their needs in an extension study.See study design
What are the potential side effects?
Potential side effects of TransCon PTH may include reactions at the injection site such as redness or pain, headaches, nausea, muscle cramps or spasms due to changes in calcium levels. Long-term effects are being studied since this is part of what the trial aims to discover.
PaTH Forward Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good.
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My growth plates in my wrist and hand have fully developed, confirmed by an x-ray.
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I can give myself daily injections or have someone who can do it for me.
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I take at least 400 mg of calcium citrate or carbonate twice a day.
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I am taking a specific dose of active vitamin D.
PaTH Forward Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
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 During the Blinded Period
Secondary outcome measures
Efficacy - Key Secondary Endpoint During the Blinded Period
PaTH Forward Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: TransCon PTH 21 mcgExperimental Treatment1 Intervention
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
Group II: TransCon PTH 18 mcgExperimental Treatment1 Intervention
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
Group III: TransCon PTH 15 mcgExperimental Treatment1 Intervention
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
Group IV: Open-Label Extension PeriodExperimental Treatment1 Intervention
Subjects who complete the four-week blinded period are assigned to open-label treatment with TransCon PTH for up to 262 weeks, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized dosing.
Group V: PlaceboPlacebo Group1 Intervention
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
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Who is running the clinical trial?
Ascendis Pharma A/SLead Sponsor
11 Previous Clinical Trials
1,498 Total Patients Enrolled
David B Karpf, MDStudy DirectorAscendis Pharma A/S North American Medical Monitor/Medical Expert
1 Previous Clinical Trials
146 Total Patients Enrolled
Aimee Shu, MDStudy DirectorAscendis Pharma A/S Medical Monitor/Medical Expert
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't taken drugs affecting bone metabolism like calcitonin or fluoride in the last 12 weeks.My genetic test shows a mutation in the CaSR gene.My kidney function is good.Your body mass index (BMI) is between 17 and 40, which is a measure of your weight in relation to your height.I've been on the same medication dose for at least 12 weeks.I don't have any health issues that could stop me from finishing the trial or that would make the trial unsafe for me.I am at high risk for bone cancer due to conditions like Paget's disease, high alkaline phosphatase levels, genetic disorders, or previous radiation therapy on my bones.I have had kidney stones or a gout attack in the last year.My body does not respond well to PTH, and I have high PTH levels with low calcium.I am 18 years old or older.My growth plates in my wrist and hand have fully developed, confirmed by an x-ray.I have used bisphosphonates or denosumab in the last 2 years.My supplements are adjusted to meet specific health targets.I have had a seizure in the last 6 months not caused by low calcium.I am not using specific medications like loop diuretics or methotrexate.I have had chronic pancreatitis for at least 6 months due to surgery, auto-immune, genetic, or unknown reasons.I do not have any conditions that affect my calcium or hormone levels.I have had chronic pancreatitis for at least 6 months.I can give myself daily injections or have someone who can do it for me.I do not have conditions that affect my body's ability to absorb food or medicine.I take at least 400 mg of calcium citrate or carbonate twice a day.I haven't had serious heart issues in the last 6 months.You are allergic to PTH or any of the ingredients in the medication.My thyroid hormone replacement dose has been stable for the last 12 weeks.The person's BMI was 17-40 kg/m2 at their first visit.I haven't taken water pills in the last 4 weeks.I am not pregnant or breastfeeding and willing to use contraception during the trial.I have not used PTH-like drugs in the last 5 weeks.I have not had a stroke in the last 5 years.I have not been in a drug study within the last 8 weeks.I am taking a specific dose of active vitamin D.
Research Study Groups:
This trial has the following groups:- Group 1: TransCon PTH 15 mcg
- Group 2: TransCon PTH 18 mcg
- Group 3: Open-Label Extension Period
- Group 4: TransCon PTH 21 mcg
- Group 5: Placebo
Awards:
This trial has 0 awards, including: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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