ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Hepatic Porphyria. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Germany, Italy +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ELEVATE, a Global Observational Longitudinal Prospective Registry of Patients With Acute Hepatic Porphyria (AHP)
Overview
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.
Primary outcome measures
- Incidence of Selected Events of Interest in AHP Patients [Time frame: Up to 6 years]
Secondary outcome measures (2)
- Annualized Rate of Porphyria Attacks [Time frame: Up to 6 years]
- 12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version) [Time frame: Up to 6 years]
Eligibility criteria
Inclusion criteria
- Documented diagnosis of AHP, per physician's determination
Exclusion criteria
- Currently enrolled in a clinical trial for any investigational agent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 13 centers
- Clinical Trial Site — Birmingham
- Clinical Trial Site — Gilbert
- Clinical Trial Site — San Francisco
- Clinical Trial Site — Baltimore
- Clinical Trial Site — Boston
- Clinical Trial Site — Minneapolis
- Clinical Trial Site — New York
- Clinical Trial Site — Winston-Salem
- … and 5 more centers
France · 3 centers
- Clinical Trial Site — Bordeaux
- Clinical Trial Site — Paris
- Clinical Trial Site — Toulouse
Germany · 3 centers
- Clinical Trial Site — Berlin
- Clinical Trial Site — Chemnitz
- Clinical Trial Site — Würzburg
Belgium · 2 centers
- Clinical Trial Site — Brussels
- Clinical Trial Site — Leuven
Italy · 2 centers
- Clinical Trial Site — Milan
- Clinical Trial Site — Modena
Taiwan · 2 centers
- Clinical Trial Site — Taichung
- Clinical Trial Site — Taipei
United Kingdom · 2 centers
- Clinical Trial Site — Cardiff
- Clinical Trial Site — London
Spain · 1 center
- Clinical Trial Site — Madrid
Sweden · 1 center
- Clinical Trial Site — Stockholm
Switzerland · 1 center
- Clinical Trial Site — Zurich
Identifiers
NCT: NCT04883905 · ALN-AS1-006 · EUPAS43201