ACTIVE_NOT_RECRUITING

BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

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Conditions

Primary Hyperoxaluria Type 1PH1Lumasiran

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

Official Title

BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

Quick Facts

Study Start:2021-12-13
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04982393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis of PH1, per physician's determination
  1. * Currently enrolled in a clinical trial for any investigational agent

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alnylam Pharmaceuticals

Study Locations (Sites)

Clinical Trial Site
Phoenix, Arizona, 85016
United States
Clinical Trial Site
Washington D.C., District of Columbia, 20010
United States
Clinical Trial Site
Boston, Massachusetts, 02115
United States
Clinical Trial Site
Rochester, Minnesota, 55905
United States
Clinical Trial Site
Cincinnati, Ohio, 45229
United States
Clinical Trial Site
Pittsburgh, Pennsylvania, 15213
United States
Clinical Trial Site
Dallas, Texas, 75390
United States
Clinical Trial Site
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Alnylam Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-13
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2021-12-13
Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

  • PH1
  • Lumasiran
  • Primary Hyperoxaluria Type 1

Additional Relevant MeSH Terms

  • Primary Hyperoxaluria Type 1