Clinical Trials Logo
  1. Home
  2. Hypoparathyroidism
  3. NCT04209179

A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism

Hypoparathyroidism Clinical Trial

Official title:
A Randomized, Double-Blind, Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PCO371 in Patients With Hypoparathyroidism

Clinical Trial Summary

This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04209179
Study type Interventional
Source Chugai Pharmaceutical
Contact
Status Terminated
Phase Phase 1
Start date July 23, 2020
Completion date May 25, 2021
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03364738 - Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism Phase 3
Active, not recruiting NCT00856401 - ADD-ON Study to Existing Hypoparathyroidism Studies Phase 3
Completed NCT05043584 - Near-infrared Autofluorescence (NIRAF)-Guided Total Thyroidectomy: Impact in Low-volume, Non-parathyroid Institutions N/A
Completed NCT03728959 - Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism. N/A
Not yet recruiting NCT06445036 - Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.
Recruiting NCT05556629 - A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using NATPARA
Terminated NCT00395538 - Effects of PTH Replacement on Bone in Hypoparathyroidism Phase 3
Completed NCT02910466 - A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism Phase 4
Completed NCT00001304 - Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34 Phase 2
Completed NCT04569604 - QoL and Cognitive Function in Patients With Hypoparathyroidism
Completed NCT06449729 - Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism
Completed NCT03747029 - Serum Calcium to Phosphorous (Ca/P) Ratio in the Diagnosis of Ca-P Metabolism Disorders: a Multicentre Study
Completed NCT05684029 - Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
Not yet recruiting NCT06419270 - Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism
Completed NCT00473265 - Bone Properties in Hypoparathyroidism: Effects of PTH Phase 2/Phase 3
Active, not recruiting NCT05328076 - Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography
Completed NCT03150108 - Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects Phase 1
Completed NCT04059380 - Evaluation of iMmune Function in Post-surgical and AuToimmune HYpoparathyroidism (EMPATHY)
Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1