Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
NCT ID: NCT04056481
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Givosiran
givosiran (ALN-AS1) administered as a subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have adequate venous access for program sample collections as judged by the Investigator for study sample collections
Exclusion Criteria
* 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) \<15 mL/min/1.73 m2
* On an active liver transplantation waiting list
12 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Other Identifiers
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ALN-AS1-005
Identifier Type: -
Identifier Source: org_study_id
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