Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.
givosiran (ALN-AS1) administered as a subcutaneous (SC) injection
Other Name: ALN-AS1
- Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
- Experienced a porphyria attack and be considered by their treating physician to be at risk for having an attack in the future.
- Have adequate venous access for program sample collections as judged by the Investigator for study sample collections
- Previously or currently participating in a givosiran clinical trial
- Has any of the following laboratory parameter assessments at Screening: 1. Alanine aminotransferase (ALT) >2×ULN 2. Total bilirubin >1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is <2×ULN 3. Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2
- On an active liver transplantation waiting list
Alnylam EAP Hotline
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.