4 completed, 1 approved for marketing. 3 Phase 1, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
Follow givosiran: new trials by email Literature Review of givosiran trials Research Report on givosiran
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP) Givosiran, 5-probe cocktail - Acute Intermittent Porphyria (AIP), Acute Hepatic Porphyria (AHP) | Phase 1 | Completed | Alnylam Pharmaceuticals | 10 | 2018-04-26 | 2019-03-12 |
| ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP) Givosiran, Placebo - Acute Hepatic Porphyria, Acute Intermittent Porphyria | Phase 3 | Completed | Alnylam Pharmaceuticals | 94 | 2017-11-16 | 2024-04-22 |
| A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP) Givosiran - Acute Intermittent Porphyria | Phase 1 / Phase 2 | Completed | Alnylam Pharmaceuticals | 16 | 2016-10-01 | 2024-03-12 |
| A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP) givosiran (ALN-AS1), Sterile Normal Saline (0.9% NaCl) - Acute Intermittent Porphyria | Phase 1 | Completed | Alnylam Pharmaceuticals | 40 | 2015-05-06 | 2018-06-14 |
| Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria Givosiran - Acute Hepatic Porphyria | Approved for marketing | Alnylam Pharmaceuticals | 2024-05-20 |
Porphyria, Acute Intermittent (5) · Porphyrias (5) · Coproporphyria, Hereditary (3) · Porphyria, Variegate (2)
Sweden (4) · United Kingdom (3) · United States (3) · Australia (1) · Bulgaria (1) · Canada (1) · Denmark (1) · Finland (1) · France (1) · Germany (1) · Italy (1) · Japan (1) · Mexico (1) · Netherlands (1) · Poland (1)
Amy Simon, MD (1) · Nader Najafian, MD (1)
PMID 39363243, PMID 30726693, PMID 32521132, PMID 36028858, PMID 37479139, PMID 38044204, PMID 41388232
2016 (1)