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

NCT ID: NCT01455181

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-19
• Study Completion Date: 2012-04-26

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.

Conditions

Hypoparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPSP558

Group Type: EXPERIMENTAL

NPSP558

Intervention Type: DRUG

50, 75, 100 μg

Interventions

NPSP558

50, 75, 100 μg

Intervention Type: DRUG

Other Intervention Names

REPEAT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Semmelweis University Medical School

Budapest, , Hungary

University of Pécs, School of Medicine

Pécs, , Hungary

University of Szeged

Szeged, , Hungary

Countries

Hungary

References

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.

Reference Type: RESULT

PMID: 26684150 (View on PubMed)

Other Identifiers

2011-001265-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PAR-C10-009

Identifier Type: -

Identifier Source: org_study_id