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NCT Number: NCT01455181

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

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.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Semmelweis University Medical School, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Signed and dated informed consent form (ICF) before any study-related procedures are performed
  • 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
  • Able to perform daily SC self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh
  • Willingness and ability to understand and comply with the protocol
  • 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:

  • Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558
  • 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
  • Pregnant or lactating woman

Treatment and study plan

NPSP558

Drug

50, 75, 100 μg

Other names: REPEAT

Primary outcomes

  1. Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.

    Time frame: 24 Weeks

    A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.

Secondary outcomes

  1. Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit

    Time frame: 24 Weeks

  2. Mean Percentage Changes From Baseline in Oral Calcium at Each Visit

    Time frame: 24 Weeks

  3. Proportion of Patients Achieving the Primary Endpoint at Each Visit

    Time frame: 24 Weeks

    A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.

  4. Mean Change From Baseline in 24-hour Urine Calcium Excretion

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Acronym: REPEAT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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