ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)

Study identification

• EU PAS number:
  EUPAS43201
• Study ID:
  43202
• Official title and acronym:
  ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Netherlands

  Sweden

  Switzerland

  Taiwan

  United Kingdom

  United States
• Study description:
  This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Multiple centres: 31 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 19/11/2020

Study start date

Actual: 26/04/2021

Data analysis start date

Planned: 30/06/2027

Date of final study report

Planned: 31/10/2027

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-AS1-006,CT.gov NCT04883905