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

March 28, 2024 updated by: Takeda

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo.

Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Marc LeMire
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincents Hospital Melbourne - PPDS
        • Principal Investigator:
          • Matthew Conron
        • Contact:
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • LKH-Universitätsklinikum Graz
        • Contact:
        • Principal Investigator:
          • Martin Wagner
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien (Medical University of Vienna)
        • Contact:
        • Principal Investigator:
          • Mattias Mandorfer
  • Belgium
      • Antwerpen, Belgium, 2650
        • Recruiting
        • UZ Antwerpen
        • Contact:
        • Principal Investigator:
          • Sven Francque
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Contact:
        • Principal Investigator:
          • Jef Verbeek
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Recruiting
        • Inspiration Research Limited
        • Principal Investigator:
          • Kenneth Chapman
        • Contact:
  • France
      • Clichy, France, 92110
        • Recruiting
        • Hopital Beaujon
        • Contact:
        • Principal Investigator:
          • Audrey Payancé
      • Lyon, France, 69317
        • Recruiting
        • Hôpital de La Croix Rousse
        • Contact:
        • Principal Investigator:
          • Teresa Antonini
      • Rennes, France, 35000
        • Recruiting
        • Hopital PONTCHAILLOU CHU de Rennes
        • Principal Investigator:
          • Edouard Bardou-Jacquet
        • Contact:
      • Toulouse, France, 31000
        • Recruiting
        • Hospital Purpan
        • Contact:
        • Principal Investigator:
          • Lauren Alric
      • Val-de-Marne, France, 94805
        • Recruiting
        • Hopital Paul Brousse
        • Contact:
        • Principal Investigator:
          • Audrey Coilly
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Universitatsklinikum der RWTH Aachen
        • Contact:
        • Principal Investigator:
          • Pavel Strnad
      • Berlin, Germany, 13353
        • Recruiting
        • Charité - Campus Virchow-Klinikum-Ostring 1
        • Contact:
        • Principal Investigator:
          • Frank Tacke
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Principal Investigator:
          • Christoph Berg
        • Contact:
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:
        • Principal Investigator:
          • Angelo Corsico
  • Poland
      • Slaskie, Poland, 41-400
        • Recruiting
        • ID Clinic Arkadiusz Pisula
        • Principal Investigator:
          • Ewa Janczewska
        • Contact:
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • CCA Hospital Braga
        • Contact:
        • Principal Investigator:
          • Carla Rolanda
      • Funchal, Portugal, 9000-168
        • Recruiting
        • Hospital Nélio Mendonça
        • Contact:
        • Principal Investigator:
          • Vitor Pereira
      • Porto, Portugal, 4099-003
        • Recruiting
        • Centro Hospitalar do Porto
        • Contact:
        • Principal Investigator:
          • Luis Maia
  • Spain
      • Barcelona, Spain, 8025
        • Recruiting
        • Hospital Universitario Vall d'Hebron - PPDS
        • Contact:
        • Principal Investigator:
          • Monica Pons Delgado
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Principal Investigator:
          • Guido Stirnimann
        • Contact:
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Principal Investigator:
          • Ashwin Dhanda
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Principal Investigator:
          • Meagan Gray
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Justin Reynolds
      • Phoenix, Arizona, United States, 85054-4502
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Hugo Vargas
      • Tucson, Arizona, United States, 85724-5136
        • Recruiting
        • University of Arizona Thomas D. Boyer Liver Institute
        • Contact:
        • Principal Investigator:
          • Geoffrey Block
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Gastroenterology & Liver Institute
        • Principal Investigator:
          • Naveen Gara
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego, Altman Clinical and Translational Institute
        • Principal Investigator:
          • Rohit Loomba
        • Contact:
      • Los Angeles, California, United States, 90095-8344
        • Recruiting
        • David Geffen School of Medicine at UCLA
        • Principal Investigator:
          • Igor Barjaktarevic
        • Contact:
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Paul Kwo
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California Benioff Children's Hospital
        • Contact:
        • Principal Investigator:
          • Philip Rosenthal
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Virginia Clark
        • Contact:
      • Miami, Florida, United States, 33136-1051
        • Recruiting
        • Schiff Center for Liver Diseases/University of Miami
        • Principal Investigator:
          • Eugene Schiff
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Nitika Gupta
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine - Indianapolis
        • Contact:
        • Principal Investigator:
          • Raj Vuppalanchi
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Principal Investigator:
          • Tomohiro Tanaka
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Womens Hospital
        • Contact:
        • Principal Investigator:
          • Nikroo Hashemi
      • Boston, Massachusetts, United States, 02118-2908
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Arpan Mohanty
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital
        • Contact:
        • Principal Investigator:
          • Robert Fontana
      • Novi, Michigan, United States, 48377-3600
        • Recruiting
        • Henry Ford Medical Center - Columbus
        • Principal Investigator:
          • Stuart Gordon
        • Contact:
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032-1559
        • Recruiting
        • Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN
        • Contact:
        • Principal Investigator:
          • Dana Goldner
      • New York, New York, United States, 10032-3722
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Monica Goldklang
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106-1716
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Seth Sclair
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
        • Principal Investigator:
          • Timothy Craig
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Charlie Strange
    • Tennessee
      • Nashville, Tennessee, United States, 37232-0028
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Roman Perri
    • Texas
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • The Texas Liver Institute
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours St. Mary's Hospital
        • Principal Investigator:
          • Mitchell Shiffman
        • Contact:
      • Richmond, Virginia, United States, 23298-5028
        • Recruiting
        • VCU Medical Center North Hospital
        • Contact:
        • Principal Investigator:
          • Amon Asgharpour

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.
  • The participant, of any sex, is aged 18 to 75 years, inclusive.
  • The participant's liver biopsy core sample collected should meet the requirements of the protocol.
  • The participant has evidence of METAVIR stage F2, F3, or F4 liver fibrosis, evaluated by a centrally read baseline liver biopsy during the screening period; or confirmed as meeting all the entry criteria by central reading of a previous biopsy conducted within 6 months before the estimated enrollment date using an adequate liver biopsy and slides as defined in the study laboratory manual.
  • The participant has a pulmonary status meeting the protocol's requirements.
  • It must be confirmed that the participant does not have HCC. Participants will be screened for HCC with alpha-fetoprotein (AFP) and abdominal ultrasound. If the participant has any of the following, they will be required to have contrast-enhanced CT or MRI imaging to exclude HCC before randomization.
  • 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 is a nonsmoker for at least 12 months before screening.

Exclusion Criteria

  • The participant has a history of liver decompensating events (overt hepatic encephalopathy [West Haven Grade >=2] documented by a physician, clinically significant ascites, spontaneous bacterial peritonitis, GI bleeding from varices, hepatopulmonary syndrome, hepatorenal syndrome, portal pulmonary hypertension, or portal gastropathy).
  • The participant has a history of the presence of medium or large varices or varices with red wale signs based on a previous esophagogastroduodenoscopy (EGD) within 6 months before the estimated enrollment date. For certain participants, an EGD will be required at screening if there is no EGD available within 6 months before the estimated enrollment date. Presence of small varices with no red wale signs on EGD and no history of bleeding will be acceptable for study eligibility.
  • The participant has evidence of other forms of chronic liver diseases, including viral hepatitis B or C, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic hepatitis, hemochromatosis, liver cancer, history of biliary diversion, or autoimmune hepatitis.
  • The participant has alanine transaminase (ALT) or aspartate transaminase (AST) levels >250 units per liter (U/L).
  • The participant has a platelet count <60,000 per cubic millimeter (mm^3) (<60 × 10^9 per liter [10^9/L]).
  • The participant has albumin <=2.8 gram per deciliter (g/dL) (28 grams per deciliter [g/L]).
  • The participant has international normalized ratio (INR) >=1.7.
  • The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
  • The participant has a history of drug abuse (such as cocaine, phencyclidine) within 1 year before the screening visit or has a positive urine drug screen at screening.
  • The participant has previously been treated with fazirsiran or any other RNAi for AATD-LD.
  • The participant has portal vein thrombosis.
  • The participant has a prior transjugular portosystemic shunt procedure.
  • The participant has a history of malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively treated malignancies who have no evidence of metastatic disease and a greater than 1-year disease-free interval may be entered after approval by the medical monitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fazirsiran
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.
Drug: Fazirsiran Injection
Participants will receive fazirsiran 200 mg/ml SC injection on Day 1, at Week 4, and Q12 W thereafter up to Week 196.
Other Names:
  • TAK-999, ARO-AAT, ADS-001
Placebo Comparator: Placebo
Participants will receive placebo on Day 1, at Week 4, and Q12 W thereafter up to Week 196.
Other: Placebo
Participants will receive placebo (sterile normal saline [0.9% NaCl]) SC injection on Day 1, at Week 4, and Q12 W thereafter up to Week 196.
Other Names:
  • Sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, Week 106
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 will be assessed.
Baseline, Week 106

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction From Baseline of at Least 1 Stage of Histologic Fibrosis (METAVIR Staging) in the Centrally Read Liver Biopsy
Time Frame: Baseline, Week 106 and Week 202
Reduction from baseline of at least 1 stage of histologic fibrosis (METAVIR Staging) in the centrally read liver biopsy in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106 and Week 202
Number of Participants With Liver Related Clinical Events up to Week 202
Time Frame: Baseline up to Week 202
Number of participants with any qualifying liver-related clinical events up to Week 202 in AATD-LD with METAVIR stage F2 to F4 fibrosis will be assessed.
Baseline up to Week 202
Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) Protein
Time Frame: Baseline, Week 106, Week 202
Change from baseline in serum Z-AAT protein in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106, Week 202
Change From Baseline in Intrahepatic Z-AAT Protein Polymer Burden Assessed by Periodic Acid Schiff Plus Diastase (PAS+D) Staining
Time Frame: Baseline, Week 106, Week 202
Change from baseline in intrahepatic Z-AAT protein polymer burden assessed by PAS+D staining liver biopsy in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106, Week 202
Change From Baseline in Intrahepatic Portal Inflammation
Time Frame: Baseline, Week 106, Week 202
Change from baseline in intrahepatic portal inflammation liver biopsy in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106, Week 202
Change From Baseline in Vibration-Controlled Transient Elastography (VCTE)/Magnetic Resonance Elastography (MRE)-derived Liver Stiffness
Time Frame: Baseline, Week 106, Week 196 and Week 202
Change from baseline in VCTE/MRE-derived liver stiffness in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106, Week 196 and Week 202
Change From Baseline in Model of End-Stage Liver Disease (MELD) Score
Time Frame: Baseline, Week 106, and Week 202
The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78*log e serum bilirubin (milligram per deciliter [mg/dL]) + 11.20* log e INR + 9.57* log e serum creatinine (mg/dL) + 6.43 (constant for liver disease etiology). The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome. Change from baseline in MELD score in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106, and Week 202
Change From Baseline in Liver Injury
Time Frame: Baseline, Week 106 and Week 202
Change from baseline in liver injury in participants with AATD-LD with METAVIR stage fibrosis will be assessed.
Baseline, Week 106 and Week 202
Observed Plasma Concentrations of Fazirsiran
Time Frame: Pre-dose up to Week 196
Observed Plasma Concentrations of Fazirsiran will be assessed.
Pre-dose up to Week 196
Number of Participants with Treatment-emergent adverse event (TEAE) and Serious TEAEs
Time Frame: From start of study drug administration up to end of the study (EOS) (Week 220)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. An SAE is any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE is any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs will be assessed.
From start of study drug administration up to end of the study (EOS) (Week 220)
Number of Participants with Clinically Significant Declines in Lung Function Parameters
Time Frame: From start of study drug administration up to EOS (Week 220)
Standard pulmonary function parameters measured will be used to study lung function.
From start of study drug administration up to EOS (Week 220)
Change From Baseline in Whole Lung PD15 (15th percentile point) Measured by CT lung Densitometry
Time Frame: Baseline up to EOS (Week 220)
Change from baseline in whole lung PD15 (15th percentile point) as measured by CT lung densitometry will be assessed.
Baseline up to EOS (Week 220)
Number of Participants with Clinically Significant Change in Vital Signs
Time Frame: From start of study drug administration up to EOS (Week 220)
Vital signs will include body temperature, respiratory rate, blood pressure, pulse and amount of oxygen in the blood. Any change in vital signs which are deemed clinically significant by the investigator will be reported as AE.
From start of study drug administration up to EOS (Week 220)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time Frame: From start of study drug administration up to EOS (Week 220)
12-lead ECG will be evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator will be reported as AE.
From start of study drug administration up to EOS (Week 220)
Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessments
Time Frame: From start of study drug administration up to EOS (Week 220)
Clinical laboratory assessments include hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.
From start of study drug administration up to EOS (Week 220)
Percent Change from Baseline in Intrahepatic Z-AAT Protein in Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (AATD-LD) with METAVIR Stage F2 to F3 Fibrosis at Week 106
Time Frame: Baseline, Week 106
Percent change from baseline in intrahepatic Z-AAT protein in AATD-LD with METAVIR stage F2 to F3 fibrosis will be assessed.
Baseline, Week 106
Percent Change from Baseline in Intrahepatic Z-AAT Protein in AATD-LD With METAVIR Stage F2 to F4 Fibrosis
Time Frame: Baseline, Week 106 and Week 202
Percent change from baseline in intrahepatic Z-AAT protein in AATD-LD with METAVIR stage F2 to F4 fibrosis will be assessed.
Baseline, Week 106 and Week 202

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

Takeda Development Center Americas, Inc.

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-999-3001
  • 2022-501943-34 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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