ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)
Status: | Active, not recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/14/2019 |
Start Date: | November 1, 2017 |
End Date: | September 2021 |
ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias
The purpose of this study is to evaluate the effect of subcutaneous givosiran (ALN-AS1),
compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic
Porphyrias (AHP).
compared to placebo, on the rate of porphyria attacks in patients with Acute Hepatic
Porphyrias (AHP).
Inclusion Criteria:
- ≥ 12 years of age
- Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary
Corproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
- Elevated urinary or plasma PBG or ALA values within the past year,
- Have active disease, with at least 2 documented porphyria attacks within the last 6
months
- Willing to discontinue or not initiate the use of prophylactic hemin throughout the
study.
- Women of child bearing potential must have a negative serum pregnancy test, not be
nursing, and use acceptable contraception
Exclusion Criteria:
- Clinically significant abnormal laboratory results
- Anticipated liver transplantation
- History of multiple drug allergies or intolerance to subcutaneous injections
- Active HIV, hepatitis C virus, or hepatitis B virus infection(s)
- History of recurrent pancreatitis
We found this trial at
12
sites
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