150 Participants Needed

Registry for Acute Hepatic Porphyria

(ELEVATE Trial)

Recruiting at 29 trial locations
AC
Overseen ByAlnylam Clinical Trial Information Line
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Alnylam Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world information about acute hepatic porphyria (AHP), a rare liver condition, from patients. Researchers seek to understand how AHP affects individuals over time and how treatments, such as givosiran (an RNA interference therapy) and other approved therapies, perform in everyday life. The trial seeks participants diagnosed with AHP by their doctor who are not part of another trial. This information will help improve care for those living with AHP. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment benefits more patients in real-world settings, offering valuable insights for those considering participation.

Why are researchers excited about this trial?

Researchers are excited about the ELEVATE registry for patients with Acute Hepatic Porphyria (AHP) because it aims to gather comprehensive data that could lead to better understanding and management of this rare condition. Unlike standard treatments that often focus on managing symptoms, this registry could provide insights into patient experiences, long-term outcomes, and the effectiveness of various treatments over time. This could pave the way for developing more targeted therapies, improving patient care, and potentially introducing innovative treatments that go beyond traditional symptom control.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

Documented diagnosis of AHP, per physician's determination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Registry Observation

Participants are observed to characterize the natural history and real-world clinical management of AHP

Up to 6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials
81
Recruited
16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

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