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

NCT01455181 | Completed Phase 3 Results

• 2 other identifiers: PAR-C10-0092011-001265-40
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypoparathyroidism

Keywords

PTH 1-84; Hypoparathyroidism; NPSP558; Parathyroid Hormone 1-84

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 Weeks

Secondary Outcomes (4)

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

  24 Weeks

• Mean Percentage Changes From Baseline in Oral Calcium at Each Visit

  24 Weeks

• Proportion of Patients Achieving the Primary Endpoint at Each Visit

  24 Weeks

• Mean Change From Baseline in 24-hour Urine Calcium Excretion

  24 Weeks

Study Arms (1)

NPSP558

EXPERIMENTAL

Drug: NPSP558

Interventions

NPSP558 DRUG

50, 75, 100 μg

Also known as: REPEAT

NPSP558

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form (ICF) before any study-related procedures are performed

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shire: lead

Study Sites (3)

Semmelweis University Medical School

Budapest, Hungary

Location

University of Pécs, School of Medicine

Pécs, Hungary

Location

University of Szeged

Szeged, Hungary

Location

Related Publications (1)

• 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.

  PMID: 26684150 RESULT

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 19, 2011
• Study Start: August 19, 2011
• Primary Completion: April 26, 2012
• Study Completion: April 26, 2012
• Last Updated: June 11, 2021
• Results First Posted: March 6, 2015

Record last verified: 2021-05

Locations

HU (3)