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Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Testing Fazirsiran's safety for liver disease with abnormal protein.

Recruiting
18-75 years
All
Phase 3

This study aims to see if a new medicine called fazirsiran can help people with liver scarring from a protein problem called Alpha-1 Antitrypsin Deficiency (AATD). AATD is when a protein, alpha-1 antitrypsin, doesn't work right, leading to liver and lung issues. The study will compare fazirsiran to a placebo, which is a treatment that doesn’t contain any active medicine. Participants may need to have liver biopsies, which are small tissue samples from the liver, twice during the study. This helps check for liver scarring (fibrosis), which is a thickening or scarring of the liver due to damage. The study will look at how well fazirsiran works compared to the placebo and check for any side effects. It will also study how the body handles fazirsiran.

  • The study lasts for a specific period and involves taking liver biopsies twice.
  • Participants will either receive fazirsiran or a placebo.
  • Participants must be between 18-75 years old and have specific liver conditions.

Participants should not have any other severe liver diseases or a history of drug abuse. They also must not have been treated with fazirsiran before.

Study details
    Alpha1-Antitrypsin Deficiency

NCT05677971

Takeda

3 May 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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