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Givosiran

DRUG4 trials

Sponsors

Alnylam Pharmaceuticals

Conditions

ALA Dehydratase Deficient Porphyria (ADP)Acute Hepatic PorphyriaAcute Hepatic Porphyria (AHP)Acute Intermittent PorphyriaAcute Intermittent Porphyria (AIP)Acute PorphyriaHereditary Coproporphyria (HCP)Porphyria, Acute Intermittent

Phase 1

A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
CompletedNCT02949830
Alnylam PharmaceuticalsAcute Intermittent Porphyria
Start: 2016-10-31End: 2021-11-05Updated: 2024-03-12
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
CompletedNCT03505853
Alnylam PharmaceuticalsAcute Hepatic Porphyria (AHP), Acute Intermittent Porphyria (AIP), Acute Porphyria +1
Start: 2018-04-26End: 2019-01-10Updated: 2019-03-12

Phase 3

ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
CompletedNCT03338816
Alnylam PharmaceuticalsAcute Hepatic Porphyria, Acute Intermittent Porphyria, Acute Porphyria +4
Start: 2017-11-16End: 2021-05-31Updated: 2024-04-22

Unknown Phase

Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria
NCT04056481
Alnylam PharmaceuticalsAcute Hepatic Porphyria
Updated: 2024-05-20

Related Papers

Platform Assessment of Concentration-QTc Relationship Across GalNAc-siRNA Molecules.
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Long-term follow-up of givosiran treatment in patients with acute intermittent porphyria from a phase 1/2, 48-month open-label extension study.
2024-10-032 citations
A randomized, placebo-controlled study of givosiran in patients with acute hepatic porphyrias (ENVISION): Final (36-month) analysis of the Taiwan Cohort.
2023-12-023 citations
Efficacy and safety of givosiran for acute hepatic porphyria: Final results of the randomized phase III ENVISION trial.
2023-07-2030 citations
Disease burden in patients with acute hepatic porphyria: experience from the phase 3 ENVISION study.
2022-08-2623 citations
Efficacy and safety of givosiran for acute hepatic porphyria: 24‐month interim analysis of the randomized phase 3 ENVISION study
Liver International2021-10-3074 citations
S1170 Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyria: 24-Month Interim Analysis of the Phase 3 ENVISION Randomized Clinical Trial
The American Journal of Gastroenterology2021-10-012 citations
S1063 Disease Burden in Patients With Acute Hepatic Porphyria: Experience From the Phase 3 ENVISION Study
The American Journal of Gastroenterology2021-10-01
Eighteen-Month Interim Analysis of Efficacy and Safety of Givosiran, an RNAi Therapeutic for Acute Hepatic Porphyria, in the Envision Open Label Extension
Blood2020-11-046 citations
S1154 Clinical Outcomes in Patients With Acute Hepatic Porphyria Treated With Givosiran Who Stopped Hemin Prophylaxis at Study Entry: A Post Hoc Analysis of Data From the Phase 3 ENVISION Study Through Month 12
The American Journal of Gastroenterology2020-10-015 citations
S1169 Twelve-Month Interim Analysis of Efficacy and Safety of Givosiran, an Investigational RNAi Therapeutic for Acute Hepatic Porphyria, in the ENVISION Open Label Extension
The American Journal of Gastroenterology2020-10-013 citations
Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria
New England Journal of Medicine2020-06-10559 citations
Leading RNA Interference Therapeutics Part 2: Silencing Delta-Aminolevulinic Acid Synthase 1, with a Focus on Givosiran.
2020-02-0154 citations
996 Disease Characteristics of Acute Hepatic Porphyria Patients: ENVISION, a Phase 3 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
The American Journal of Gastroenterology2019-10-011 citations