This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype

Sponsored by Vertex Pharmaceuticals Incorporated

About this trial

Last updated 2 years ago

Study ID

VX22-864-108

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 months ago

What is this trial about?

The purpose of this study is to evaluate the efficacy and safety of VX-864 in participants with the PiZZ genotype over 48 weeks.

What are the Participation Requirements?

Key Inclusion Criteria:

- Participants must have a PiZZ genotype confirmed at screening

- Plasma AAT levels indicating severe deficiency at screening

Key Exclusion Criteria:

- History of a medical condition that could negatively impact the ability to complete
the study

- Solid organ, or hematological transplantation or is currently on a transplant list

- History of use of gene therapy or Ribonucleic acid interference (RNAi) therapy at any
time previously

- Participants for whom discontinuation of augmentation therapy is not considered to be
in their best interest, based on the clinical judgement of the treating physician

Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Active, not recruiting
Active, not recruiting
Active, not recruiting