Status:
APPROVED_FOR_MARKETING
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Acute Hepatic Porphyria
Eligibility:
All Genders
12+ years
Brief Summary
The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).
Detailed Description
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 abou...
Eligibility Criteria
Inclusion
- Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
- Have adequate venous access for program sample collections as judged by the Investigator for study sample collections
Exclusion
- Previously or currently participating in a givosiran clinical trial
- Has any of the following laboratory parameter assessments at Screening:
- Alanine aminotransferase (ALT) \>2×ULN
- 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
- Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73 m2
- On an active liver transplantation waiting list
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04056481
Last Update
May 20 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.