Clinical trial NCT01455181: A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary
Official title: A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoparathyroidism
Keywords: PTH 1-84
Hypoparathyroidism
NPSP558
Parathyroid Hormone 1-84
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Detailed description: Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.

Eligibility criteria: Inclusion Criteria:

Patients who meet all the following inclusion criteria can be enrolled into this study:

1. Signed and dated informed consent form (ICF) before any study-related procedures are performed
2. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR Enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE
3. Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh
4. Willingness and ability to understand and comply with the protocol
5. Women who are: (1) postmenopausal defined as 12 months amenorrhea with appropriate serum follicle stimulating hormone (FSH) levels (\> 40 IU/L); (2) surgically sterilized; OR (3) of childbearing potential with a negative pregnancy test at screening and who consent to use two acceptable methods of contraception for the duration of the study, with pregnancy testing at every scheduled visit during the treatment period . Female partners (who are of childbearing potential) of male study patients must also use acceptable forms of contraception during their partner's participation

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 woman

Primary outcomes:
measure: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
timeFrame: 24 Weeks
Secondary outcomes:
measure: Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
timeFrame: 24 Weeks
measure: Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
timeFrame: 24 Weeks
measure: Proportion of Patients Achieving the Primary Endpoint at Each Visit
timeFrame: 24 Weeks
measure: Mean Change From Baseline in 24-hour Urine Calcium Excretion
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Medical School
city: Pécs
country: Hungary
facility: University of Pécs, School of Medicine
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Lakatos P, Bajnok L, Lagast H, Valkusz Z. AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH HYPOPARATHYROIDISM. Endocr Pract. 2016 May;22(5):523-32. doi: 10.4158/EP15936.OR. Epub 2015 Dec 18.