ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

Brief Title

ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

Official Title

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

Brief Summary

      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 Type

Observational


Primary Outcome

Incidence of Selected Events of Interest in AHP Patients

Secondary Outcome

 Annualized Rate of Porphyria Attacks

Condition

Acute Hepatic Porphyria


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

April 26, 2021

Completion Date

April 2027

Primary Completion Date

April 2027

Eligibility Criteria

        Inclusion Criteria:

          -  Documented diagnosis of AHP, per physician's determination

        Exclusion Criteria:

          -  Currently enrolled in a clinical trial for any investigational agent
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Director, 1-877-ALNYLAM, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04883905

Organization ID

ALN-AS1-006


Responsible Party

Sponsor

Study Sponsor

Alnylam Pharmaceuticals


Study Sponsor

Medical Director, Study Director, Alnylam Pharmaceuticals


Verification Date

July 2021