Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name REPEAT

NCTNCT01455181Other idPAR-C10-009Other id2011-001265-40

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 24 participants (actual)
Sponsor: Shire · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Hungary
Start: 19 Aug 2011
Primary completion: 26 Apr 2012
Completion: 26 Apr 2012
First posted: 19 Oct 2011 (estimated)
Last update posted: 11 Jun 2021
Conditions: Hypoparathyroidism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

Ph 3
REPEAT
NCT01455181
19 Aug 2011 to 26 Apr 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

NPSP558Drug

Arms1

Experimental
NPSP558

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.
Time frame · 24 Weeks
Registry description
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(4)

Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit
Time frame · 24 Weeks
Mean Percentage Changes From Baseline in Oral Calcium at Each Visit
Time frame · 24 Weeks
Proportion of Patients Achieving the Primary Endpoint at Each Visit
Time frame · 24 Weeks
Registry description
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.
Mean Change From Baseline in 24-hour Urine Calcium Excretion
Time frame · 24 Weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 Weeks

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

Group	Value (percentage of participants)
NPSP558	75.0

Secondary and other outcome results(4)

Secondary outcomeMean· 24 Weeks

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

Group	Value (percentage of change)	Spread
NPSP558	-47.08	31.566

Secondary outcomeMean· 24 Weeks

Mean Percentage Changes From Baseline in Oral Calcium at Each Visit

Group	Value (percentage of change)	Spread
NPSP558	-8.3	36.20

Secondary outcomeNumber· 24 Weeks

Proportion of Patients Achieving the Primary Endpoint at Each Visit

Group	Value (percentage of participants)
NPSP558	20.8

Secondary outcomeMean· 24 Weeks

Mean Change From Baseline in 24-hour Urine Calcium Excretion

Group	Value (mg/24 hour)	Spread
NPSP558	-64.58	188.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
NPSP558NPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50, 75, or 100 mcg subcutaneously daily.	–	0 / 24	22 / 24

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

6 results

AN OPEN-LABEL EXTENSION STUDY OF PARATHYROID HORMONE RHPTH(1-84) IN ADULTS WITH HYPOPARATHYROIDISM.

Lakatos et al. 2016Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 18

PMID 26684150DOI 10.4158/ep15936.orPUB-26684150

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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