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Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

NCT03364738 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-10-07

Study results available
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Summary

This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in adults with hypoparathyroidism who previously participated in the SHP634-101 study. All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection.

Patients who complete the SHP634-101 study will have the option to screen for this extension study.

Conditions

  • Hypoparathyroidism

Interventions

BIOLOGICAL

rhPTH(1-84)

Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2020-04-14
Completion
2020-04-14
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03364738 on ClinicalTrials.gov