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PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism

NCT05387070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-01-16

No results posted yet for this study

Summary

This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.

Conditions

  • Hypoparathyroidism
  • Parathyroid Hormone Deficiency
  • Endocrine System Diseases
  • Parathyroid Diseases

Interventions

DRUG

TransCon PTH

TransCon PTH is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for SC injection.

DRUG

placebo

Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.

Sponsors & Collaborators

  • Visen Pharmaceuticals (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weibo Xia, MD · Department of endocrinology, Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-01-04
Completion
2026-01-08

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387070 on ClinicalTrials.gov