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NCT01417091 · ClinicalTrials.gov registry record · Phase 2

Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

A Phase 2 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target
6
Study locations

NCT01417091 is a Phase 2 study of Osteogenesis Imperfecta that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 10 participants, below the 160-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT01417091, a Phase 2 study of Osteogenesis Imperfecta, has completed, sponsored by Ultragenyx Pharmaceutical.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target
6
Study locations

Study Summary

This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI). Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.

Conditions Studied

Osteogenesis Imperfecta

Interventions

  • DRUG BPS804

Study Locations (6)

Other

  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Ghent
  • Novartis Investigative Site - Würzburg

California

  • Novartis Investigative Site - Anaheim

Florida

  • Novartis Investigative Site - Miramar

Quebec

  • Novartis Investigative Site - Montreal

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2011-06
Est. Completion 2012-12
Phase Phase 2

Sponsor

Ultragenyx Pharmaceutical

52 total trials

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What the Registry Record Tells You About NCT01417091

The ClinicalTrials.gov registry entry for NCT01417091 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 160-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (94% lower). The listed sponsor is Ultragenyx Pharmaceutical, which has 52 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 1 intervention - of which BPS804 is the first listed.

NCT01417091 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01417091 about?

NCT01417091 is a clinical study titled "Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta". This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI). Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In ...

What is the current status of trial NCT01417091?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-06. Estimated completion is 2012-12.

What conditions does trial NCT01417091 study?

This clinical trial studies the following conditions: Osteogenesis Imperfecta.

What interventions are being tested in trial NCT01417091?

The interventions under investigation include: BPS804 (DRUG).

Who is sponsoring clinical trial NCT01417091?

This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01417091 being conducted?

This trial has 6 study locations across California, Florida, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.