A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01455181
• Date of registration: 15/09/2011
• Prospective Registration: No
• Primary sponsor: Shire
• Public title: A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary REPEAT
• Scientific 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
• Date of first enrolment: August 19, 2011
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01455181
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Hungary

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypoparathyroidism

Intervention(s)

Drug: NPSP558

Primary Outcome(s)

Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. [Time Frame: 24 Weeks]

Secondary Outcome(s)

Mean Change From Baseline in 24-hour Urine Calcium Excretion [Time Frame: 24 Weeks]

Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit [Time Frame: 24 Weeks]

Proportion of Patients Achieving the Primary Endpoint at Each Visit [Time Frame: 24 Weeks]

Mean Percentage Changes From Baseline in Oral Calcium at Each Visit [Time Frame: 24 Weeks]

Secondary ID(s)

PAR-C10-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01455181