Trial record 2 of 6 for:    npsp

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharma
ClinicalTrials.gov Identifier:
NCT01455181
First received: September 15, 2011
Last updated: March 10, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Hypoparathyroidism
Drug: NPSP558
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by NPS Pharma:

Primary Outcome Measures:
  • Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Mean Percentage Changes From Baseline in Oral Calcium at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Patients Achieving the Primary Endpoint at Each Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPSP558 Drug: NPSP558
50, 75, 100 μg
Other Name: REPEAT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455181

Locations
Hungary
Semmelweis University Medical School
Budapest, Hungary
University of Pécs, School of Medicine
Pécs, Hungary
University of Szeged
Szeged, Hungary
Sponsors and Collaborators
NPS Pharma
Investigators
Study Director: Hjalmar Lagast, M.D. NPS Pharma
  More Information

No publications provided

Responsible Party: NPS Pharma
ClinicalTrials.gov Identifier: NCT01455181     History of Changes
Other Study ID Numbers: PAR-C10-009
Study First Received: September 15, 2011
Results First Received: February 20, 2015
Last Updated: March 10, 2015
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee

Keywords provided by NPS Pharma:
Hypoparathyroidism
NPSP558
Parathyroid Hormone 1-84
PTH 1-84

Additional relevant MeSH terms:
Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on August 02, 2015