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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 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 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

0 / 5Eligibility criteria met

Find a Location

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

Media Library

TransCon PTH (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04009291 — Phase 2

Hypoparathyroidism Research Study Groups: TransCon PTH 15 mcg, TransCon PTH 18 mcg, Open-Label Extension Period, TransCon PTH 21 mcg, Placebo

Hypoparathyroidism Clinical Trial 2023: TransCon PTH Highlights & Side Effects. Trial Name: NCT04009291 — Phase 2

TransCon PTH (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04009291 — Phase 2

Frequently Asked Questions

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

How reliable is TransCon PTH for patients' wellbeing?

"TransCon PTH was assigned a safety score of 2, since its phase 2 trial has provided some evidence regarding the therapy's security but no proof exists for efficacy."

Answered by AI

Are there any opportunities to take part in this trial at the moment?

"This particular trial, which was initially published on August 27th 2019 and most recently updated on September 6th 2022, is no longer looking for volunteers. However, 55 other studies are open to enrolment at present."

Answered by AI

What is the geographic scope of this research endeavor?

"Currently, 6 sites are recruiting patients for this medical trial. These locations include Great Neck, Chicago and Philadelphia among others. It might be beneficial to select a location nearby in order to reduce the need for travel if you choose to enrol."

Answered by AI