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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An adult participant must have a body mass index (BMI) between 18.0 and 39.0 kilograms per meter square (kg^m2), inclusive.
The participant must have a diagnosis of the Z allele homozygotes (PiZZ) genotype AATD. PiZZ diagnosis from source verifiable medical records is permitted. Otherwise, participants must undergo PiZZ confirmatory testing (genotyping for PiS and PiZ alleles) at screening. PiMZ or PiSZ genotypes are not permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 106, week 196 and week 202
Awards & highlights
Study Summary
This trial will test if fazirsiran can reduce liver scarring & slow disease progression in patients with Alpha-1.
Who is the study for?
Adults aged 18-75 with Alpha-1 Antitrypsin Deficiency (AATD) causing liver scarring, who are non-smokers for at least a year and have a BMI of 18.0-39.0 kg/m2 can join this trial. They must not have liver cancer, drug abuse history within the last year, certain blood or liver issues, other chronic liver diseases, recent malignancies except some skin cancers or in situ cervical cancer.Check my eligibility
What is being tested?
The study is testing if Fazirsiran injections can reduce liver scarring compared to placebo in people with AATD-related fibrosis. It will also assess how the body processes Fazirsiran and its impact on disease progression using biopsies and biomarkers.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions to Fazirsiran as compared to those receiving a placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18.0 and 39.0.
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I have been diagnosed with the PiZZ genotype for AATD.
Select...
My liver fibrosis is at stage F2, F3, or F4 based on a recent biopsy.
Select...
I do not have liver cancer, confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 106, week 196 and week 202
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 106, week 196 and week 202
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction From Baseline of at Least 1 Stage of Histologic Fibrosis (METAVIR Staging) in the Centrally Read Liver Biopsy at Week 106 in AATD-LD With METAVIR Stage F2 and F3 Fibrosis
Secondary outcome measures
Change From Baseline in Intrahepatic Portal Inflammation
Change From Baseline in Intrahepatic Z-AAT Protein Polymer Burden Assessed by Periodic Acid Schiff Plus Diastase (PAS+D) Staining
Change From Baseline in Liver Injury
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FazirsiranExperimental Treatment1 Intervention
Participants will receive fazirsiran 200 milligram per milliliter (mg/ml) subcutaneous (SC) injection on Day 1, at Week 4, and then every 12 weeks (Q12 W) thereafter up to Week 196.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo on Day 1, at Week 4, and Q12 W thereafter up to Week 196.
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Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,865 Total Patients Enrolled
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,874 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,193 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 18.0 and 39.0.I have been diagnosed with the PiZZ genotype for AATD.I have had medium or large varices, or ones with red signs, but small ones without bleeding are okay.My liver fibrosis is at stage F2, F3, or F4 based on a recent biopsy.I had cancer in the last 5 years, but it was either skin cancer, superficial bladder tumors, or in situ cervical cancer, or I've been disease-free for over a year.I have been treated with RNAi therapy for AATD-LD before.Your ALT or AST levels are higher than 250 U/L.You have used illegal drugs like cocaine or phencyclidine in the past year, or you test positive for drugs in your urine at the screening.Your platelet count is less than 60,000 per cubic millimeter.My lung function meets the study's requirements.I do not have liver cancer, confirmed by tests.I am between 18 and 75 years old.I have had serious liver-related health events.I have had a procedure to connect my liver and vein.Your albumin level is less than 2.8 g/dL.Your blood clotting test shows an international normalized ratio (INR) of 1.7 or higher.I have a chronic liver disease such as hepatitis, cirrhosis, or liver cancer.I will be exposed to harmful dust or metals at work during the study.I have a blood clot in the vein to my liver.My liver biopsy sample meets the study's requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Fazirsiran
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults of 18 years or more eligible to participate in this experiment?
"This medical research is open to patients aged 18 and above, but below 75 years old."
Answered by AI
Has Fazirsiran met the criteria for authorization from the FDA?
"Our experts gave Fazirsiran a score of 3 due to the presence of Phase 3 clinical data and multiple safety trials."
Answered by AI
Is this therapeutic research accepting participants at the moment?
"Affirmative. The particulars on clinicaltrials.gov demonstrate that this medical research, which was first announced on March 6th 2023 is currently recruiting participants. Around 160 volunteers need to be sourced from one site."
Answered by AI
How many participants are being selected for this clinical study?
"Affirmative, clinicaltrials.gov indicates that this study is actively recruiting. It was initially posted on March 6th 2023 and the latest update came out on March 14th 2023. The trial necessitates 160 participants from a single medical centre to be enrolled in it."
Answered by AI
What criteria must be met for individuals to qualify for this clinical trial?
"This clinical trial is recruiting 160 individuals suffering from alpha-1 antitrypsin deficiency between 18 and 75 years of age. The prospective patient must meet the following criteria: they should possess a PiZZ genotype AATD that can be verified via medical records or subjected to confirmatory testing (genotyping for PiS and PiZ alleles) during screening; those with either PiMZ or PISZ will not qualify, any sex aged 18 to 75 inclusive, evidence of METAVIR stage F2, F3, or F4 liver fibrosis evaluated by central read baseline biopsy during screening; participants must also have"
Answered by AI
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