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Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype

NCT04474197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-05-26

Study results available
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Summary

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ subjects.

Conditions

  • Alpha1-Antitrypsin Deficiency

Interventions

DRUG

VX-864

Tablets for oral administration.

DRUG

Placebo

Placebo matched to VX-864 for oral administration.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2021-05-04
Completion
2021-05-04
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Ireland
  • Sweden
  • 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 NCT04474197 on ClinicalTrials.gov