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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44283
• EU PAS number:
  EUPAS43242
• Study ID:
  44283
• Official title and acronym:
  BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Canada

  France

  Germany

  Israel

  Italy

  Netherlands

  Spain

  Switzerland

  United Kingdom

  United States
• Study 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Multiple centres: 32 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 19/11/2020

Study start date

Planned: 17/12/2021

Actual: 13/12/2021

Data analysis start date

Planned: 30/11/2028

Date of final study report

Planned: 01/02/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alnylam

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ALN-GO1-007,CT.gov NCT04982393