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NCT03324880 · ClinicalTrials.gov registry record · Phase 4

A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

A Phase 4 study of Hypoparathyroidism, sponsored by Shire.

Completed
Registry status
Phase 4
Development phase
93
Enrollment target
20
Study locations

NCT03324880 is a Phase 4 study of Hypoparathyroidism that has completed, run by Shire. The registered enrollment target is 93 participants, below the 190-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT03324880, a Phase 4 study of Hypoparathyroidism, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 4
Development phase
93 participants
Enrollment target
20
Study locations

Study Summary

Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-84) or a placebo. A placebo looks like the medicine being studied but does not have medicine in it. In this study, the placebo will be a standard treatment which is either active Vitamin D, or active Vitamin D with calcium. Active Vitamin D is a form of vitamin D that has a faster effect on the body. These treatments will be given as a daily injection just under the skin. Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable. All participants will also take active vitamin D and calcium supplements during treatment. Participants will record their symptoms in a tool called the hypoparathyroidism symptom diary. This tool is used to assess symptoms and their impact and will give an overall score for each participant. The study doctors will also check for side effects from the study treatments. After treatment, researchers will check if there is any difference in the diary scores between the 2 treatment groups. A difference in score means there is a difference in symptoms and their impact. From this, researchers will learn if symptoms have improved for participants treated with rhPTH(1-84) compared with those treated with placebo.

Conditions Studied

Hypoparathyroidism

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL rhPTH (1-84)

Study Locations (20)

Other

  • CHU de Quebec-Universite Laval - Québec
  • Eastern Health - Health Sciences Center- General Hospital - St. John's
  • Odense Universitetshospital - Odense C
  • CHU Angers - Angers
  • Hopital Jean Minjoz - Besançon
  • CHU Bicêtre - Le Kremlin-Bicêtre
  • CHRU Lille - Lille

Illinois

  • University of Chicago - Chicago

Michigan

  • Michigan Bone and Mineral Clinic - Detroit

Minnesota

  • Mayo Clinic - PPDS - Rochester

North Carolina

  • Physicians East PA - Greenville

Ohio

  • Ohio State University Wexner Medical Center - Columbus

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Oost-Vlaanderen

  • UZ Gent - Ghent

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2018-01-24
Est. Completion 2022-05-19
Phase Phase 4

Sponsor

Shire

245 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03324880

The ClinicalTrials.gov registry entry for NCT03324880 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (51% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoparathyroidism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03324880 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Illinois, Michigan.

Frequently Asked Questions

What is clinical trial NCT03324880 about?

NCT03324880 is a clinical study titled "A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)". Recombinant human parathyroid hormone, also known as if rhPTH(1-84), is a medicine to treat people with Hypothyroidism. The main aim of this study is to learn if rhPTH(1-84) can improve symptoms in adults with hypoparathyroidism. In this study, participants will receive 1 of 2 treatments: rhPTH(1-8...

What is the current status of trial NCT03324880?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 93 participants. The study started on 2018-01-24. Estimated completion is 2022-05-19.

What conditions does trial NCT03324880 study?

This clinical trial studies the following conditions: Hypoparathyroidism.

What interventions are being tested in trial NCT03324880?

The interventions under investigation include: Placebo (BIOLOGICAL), rhPTH (1-84) (BIOLOGICAL).

Who is sponsoring clinical trial NCT03324880?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03324880 being conducted?

This trial has 20 study locations across Illinois, Michigan, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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