Recruiting

Observational Study

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT04883905

Conditions

Acute Hepatic Porphyria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Acute Hepatic Porphyria

Study ID

NCT04883905

Start date

Apr 26, 2021

Status verified date

Sep, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented diagnosis of AHP, per physician's determination

Exclusion Criteria:

  • Currently enrolled in a clinical trial for any investigational agent

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with AHP

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

Primary outcome measure

  • Incidence of Selected Events of Interest in AHP Patients [ Time Frame: Up to 6 years ]

Central Contacts and Locations

Central contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

1-877-256-9526clinicaltrials@alnylam.com

Locations

Clinical Trial Site

Recruiting

Birmingham, Alabama, United States, 35233

Clinical Trial Site

Recruiting

Gilbert, Arizona, United States, 85234

Clinical Trial Site

Recruiting

San Francisco, California, United States, 90074

Clinical Trial Site

Recruiting

Baltimore, Maryland, United States, 21205

Clinical Trial Site

Recruiting

Boston, Massachusetts, United States, 02114

Clinical Trial Site

Recruiting

Minneapolis, Minnesota, United States, 55455

Clinical Trial Site

Recruiting

New York, New York, United States, 10029

Clinical Trial Site

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Clinical Trial Site

Recruiting

Galveston, Texas, United States, 77555

Clinical Trial Site

Recruiting

Salt Lake City, Utah, United States, 84112

Clinical Trial Site

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Givosiran
  • AHP
  • Acute hepatic porphyria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-09-08.