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ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

NCT03338816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-04-22

Study results available
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Summary

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).

Conditions

  • Acute Hepatic Porphyria
  • Acute Intermittent Porphyria
  • Porphyria, Acute Intermittent
  • Acute Porphyria
  • Hereditary Coproporphyria (HCP)
  • Variegate Porphyria (VP)
  • ALA Dehydratase Deficient Porphyria (ADP)

Interventions

DRUG

Givosiran

Givosiran by SC

DRUG

Placebo

Matching placebo (normal saline \[0.9% NaCl\]) by SC

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-16
Primary Completion
2019-01-31
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338816 on ClinicalTrials.gov