A Study to Assess the Effects of Parathyroid Hormone (rhPTH [1-84]), in Submjects with Hypoparathyroidism

• Conditions: Hypoparathyroidism; MedDRA version: 13.1Level: PTClassification code 10021041Term: HypoparathyroidismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-001265-40-HU
• Lead Sponsor: PS Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-23
• Last Update Posted: 12 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study, OR

• Enrolled in REPLACE and dropped out during screening, 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

• No evidence of any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of NPSP558

• No evidence of any disease or condition, in the opinion of the investigator, which 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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 women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified