PaTH Forward: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Trial with an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults with Hypoparathyroidism

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512967-29-00

Acronym

TransCon PTH TCP-201

Enrollment

Registered

2024-07-30

Start date

2019-09-03

Completion date

2025-03-21

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoparathyroidism (HP) in Adults

Brief summary

At 4 weeks of treatment, the proportion of subjects with: • Albumin-adjusted sCa within the normal range and • Spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline and • Not taking active vitamin D supplements and • Taking ≤1000 mg/day of calcium supplements

Detailed description

Key Secondary Efficacy Endpoint: At 4 weeks of treatment, the proportion of subjects with: • Albumin-adjusted sCa within the normal range and • FECa within the normal range or a reduction by at least 50% from baseline and • Not taking active vitamin D supplements and • Taking ≤500 mg/day of calcium supplements

Interventions

DRUGTransCon PTH

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
At 4 weeks of treatment, the proportion of subjects with: • Albumin-adjusted sCa within the normal range and • Spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline and • Not taking active vitamin D supplements and • Taking ≤1000 mg/day of calcium supplements	—

Secondary

Measure	Time frame
Key Secondary Efficacy Endpoint: At 4 weeks of treatment, the proportion of subjects with: • Albumin-adjusted sCa within the normal range and • FECa within the normal range or a reduction by at least 50% from baseline and • Not taking active vitamin D supplements and • Taking ≤500 mg/day of calcium supplements	—

Countries

Denmark, Germany, Italy, Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026