Urine Sample Collection From FOP Patients

Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis

NCT02066324•Novartis Pharmaceuticals

Summary

The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.

Eligibility

Age

5 - 35 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
•Physically able to provide first-morning urine sample of at least 30 mL
•Able to communicate well with the investigator, to understand and comply with the requirements of the study
•About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function

Exclusion Criteria

•Diagnosis of diabetes
•Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
•Diagnosis of cancer other than nonmelanomatous skin cancer.

Locations (1)

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

March 12, 2015

Enrollment

ACTUAL participants

Conditions

Fibrodysplasia Ossificans Progressiva

Saracatinib Trial TO Prevent FOP

NCT04307953

Fibrodysplasia Ossificans Progressiva

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ACTIVE_NOT_RECRUITINGPHASE3

A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)

NCT05394116

Fibrodysplasia Ossificans Progressiva

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COMPLETEDPHASE3

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Urine Sample Collection From FOP Patients

Inclusion Criteria

Exclusion Criteria

Saracatinib Trial TO Prevent FOP

A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.