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NCT05899673

An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease

StatusActive, Not Recruiting
PhasePhase 3
SponsorTakeda
Primary completion (estimated)
Track this trial

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Record History

All 14 versions: 14 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 31 → 200 participants
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 1 of 10 sites
  2. Eligibility criteria expanded, about 20 words
    • Enrollment target: estimated 37 to confirmed 31
    • Study sites: 12 to 10
    v13
  3. Primary and study completion dates: May 29, 2026 to May 2, 2033
    • Eligibility criteria expanded, about 121 words
    • Secondary endpoints revised (6)
    v12
  4. Trial status: Enrolling by Invitation to Active, Not Recruitingv11
  5. Study sites: 9 to 12v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 8 to 9v9
  2. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 1 to 8
    v8
  3. Eligibility criteria shortened, about 1 wordv7
  4. Secondary endpoints revised (6)v6
  5. Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (6)
    v5
  6. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Eligibility criteria shortened, about 1 word
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 14, 2023 to Aug 8, 2023
    • Secondary endpoints expanded, about 106 words
  7. Eligibility criteria shortened, about 21 wordsv3
  8. Study Status, Referencesv2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Timeframe: From start of study drug administration (in current study) up to End of study (EOS) (current study [up to 10 years])
Number of Participants With Clinically Significant Changes From Baseline in Pulmonary Function Parameters
Timeframe: Baseline (current study), up to EOS (current study up to 10 years])
Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: From start of study drug administration (in current study) up to EOS (current study [up to 10 years])
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Timeframe: From start of study drug administration (in current study) up to EOS (current study [up to 10 years])

Secondary (6)

Number of Participants With no Progression from Baseline of At least 1 Stage of Histologic Fibrosis on Liver Biopsy at Week 102
Number of Participants With Reduction from Baseline of At least 1 Stage of Histologic Fibrosis on Liver Biopsy at Week 102
Change from Baseline in Intrahepatic Z-AAT Protein Polymer Burden Assessed by Periodic Acid Schiff Plus Diastase (PAS+D) Staining in Liver Biopsy at Week 102
Change from Baseline in Intrahepatic Portal Inflammation Score at Week 102 in Liver Biopsy
Change from Baseline in Liver Stiffness Assessed by Magnetic Resonance Elastography (MRE)
Show 1 moreShow less
Change from Baseline in Liver Stiffness Assessed by Vibration-Controlled Transient Elastography (VCTE)

Arms and interventions

Fazirsiran 200 mgExperimental

Participants who are currently taking part in or who have completed their treatment in parent studies AROAAT2001 (NCT03945292), AROAAT2002 (NCT03946449), TAK-999-3001 \[NCT05677971\] and TAK-999-3002 (NCT06165341) will rollover in this study to receive fazirsiran, 200 milligrams (mg), injection, subcutaneously on Day 1 and once every 12 weeks (Q12W) thereafter until fazirsiran receives approval and is commercially available in the participant's country, until a participant withdraws from the study or the sponsor decides to terminate the study.

Drugs: Fazirsiran Injection

Sites

10 sites in 5 countries

United States 5, United Kingdom 2, Austria 1, Germany 1, Portugal 1