Hypoparathyroidism MedDRA version: 13.1 Level: PT Classification code 10021041 Term: Hypoparathyroidism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: PREOTACT
Product Name: Recombinant Human Parathyroid Hormone [rhPTH(1-84)]
Product Code: NPSP 558
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Pa
Sponsors
NPS Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR • Enrolled in REPLACE and dropped out during screening, but currently meet inclusion/exclusion criteria for REPLACE • Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh • No evidence of any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558 • No evidence of any disease or condition, in the opinion of the investigator, which has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria at baseline (Visit 1) are not eligible for enrollment in this study: 1. Any condition that, in the investigator's opinion after consultation with the sponsor would preclude the safe use of NPSP558 2. Any disease or condition in the opinion of the investigator that has a high probability of precluding the patient from completing the study or where the patient cannot or will not appropriately comply with study requirements 3. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the safety and tolerability of SC NPSP558 as hormone replacement therapy administered for 6 months for the treatment of hypoparathyroidism in adult patients.;Secondary Objective: To evaluate the impact of different preparations of calcium and calcitriol or alphacalcidol on the response to NPSP558 replacement therapy. To demonstrate that dosing with NPSP558 across a dose range of 50 to 100 µg SC can be implemented in a safe and effective manner and can be maintained throughout 24 weeks of treatment. ;Primary end point(s): The proportion of patients in whom the following three conditions are fulfilled at Week 24 (Visit 6) will be summarized: • A =50% reduction from baseline in dose or oral calcium supplementation or an oral calcium dose of =500 mg/day • A =50% reduction from baseline in dose of oral calcitriol/alphacalcidol supplementation or an oral calcitriol dose of =0.25 µg/day or alphacalcidol dose of =0.50 µg/day • An albumin-corrected total serum calcium concentration that is normalized or maintained compared to the baseline value and does not exceed the ULN for the central laboratory;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: • Mean percentage changes from baseline in supplemental oral calcium and supplemental calcitriol or alphcalcidol dosages at each visit • Proportion of patients achieving the primary endpoint at each visit • Mean change from baseline in 24-hour urine calcium excretion ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Hungary
Contacts
Public ContactHjalmar Lagast
NPS Pharmaceuticals, Inc.
Outcome results
None listed