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

NCT ID: NCT04982393

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2028-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hyperoxaluria Type 1

Keywords

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PH1 Lumasiran Primary Hyperoxaluria Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PH1

Patients with a diagnosis of PH1 will be eligible for the study and will be managed and treated per routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of PH1, per physician's determination

Exclusion Criteria

* Currently enrolled in a clinical trial for any investigational agent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

Phoenix, Arizona, United States

Site Status RECRUITING

Clinical Trial Site

Washington D.C., District of Columbia, United States

Site Status COMPLETED

Clinical Trial Site

Boston, Massachusetts, United States

Site Status RECRUITING

Clinical Trial Site

Rochester, Minnesota, United States

Site Status RECRUITING

Clinical Trial Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Clinical Trial Site

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Clinical Trial Site

Dallas, Texas, United States

Site Status RECRUITING

Clinical Trial Site

Houston, Texas, United States

Site Status RECRUITING

Clinical Trial Site

Ghent, , Belgium

Site Status RECRUITING

Clinical Trial Site

Liège, , Belgium

Site Status RECRUITING

Clinical Trial Site

Hamilton, Ontario, Canada

Site Status RECRUITING

Clinical Trial Site

Toronto, Ontario, Canada

Site Status RECRUITING

Clinical Trial Site

Laurier, Quebec, Canada

Site Status RECRUITING

Clinical Trial Site

Bordeaux, , France

Site Status RECRUITING

Clinical Trial Site

Lyon, , France

Site Status RECRUITING

Clinical Trial Site

Paris, , France

Site Status RECRUITING

Clinical Trial Site

Berlin, , Germany

Site Status RECRUITING

Clinical Trial Site

Cologne, , Germany

Site Status RECRUITING

Clinical Trial Site

Hamburg, , Germany

Site Status RECRUITING

Clinical Trial Site

Jerusalem, , Israel

Site Status RECRUITING

Clinical Trial Site

Orbassano, Torino, Italy

Site Status RECRUITING

Clinical Trial Site

Milan, , Italy

Site Status RECRUITING

Clinical Trial Site

Verona, , Italy

Site Status RECRUITING

Clinical Trial Site

Amsterdam, , Netherlands

Site Status RECRUITING

Clinical Trial Site

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status RECRUITING

Clinical Trial Site

Barcelona, , Spain

Site Status RECRUITING

Clinical Trial Site

Las Palmas, , Spain

Site Status RECRUITING

Clinical Trial Site

Bern, , Switzerland

Site Status RECRUITING

Clinical Trial Site

London, England, United Kingdom

Site Status RECRUITING

Clinical Trial Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Canada France Germany Israel Italy Netherlands Spain Switzerland United Kingdom

Central Contacts

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Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-ALNYLAM

Email: [email protected]

Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-256-9526

Email: [email protected]

Other Identifiers

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ALN-GO1-007

Identifier Type: -

Identifier Source: org_study_id