Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2025-02-28
2028-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
BW-20805 600 mg Q24W\*2
BW-20805
SC administrations of BW-20805 600 mg on Day1 to Day673
Cohort 2
BW-20805 300 mg Q24W\*2
BW-20805
SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673
Cohort 3
BW-20805 300 mg Q12W\*2
BW-20805
SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589
Interventions
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BW-20805
SC administrations of BW-20805 600 mg on Day1 to Day673
BW-20805
SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673
BW-20805
SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589
Eligibility Criteria
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Inclusion Criteria
* Males or females 18 to 70 years of age at the time of informed consent.
* Documented diagnosis of HAE-1/HAE-2.
* At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
* Access to and ability to use ≥ 1 acute medication(s)
* Female subjects must be non-pregnant;non-lactating, and either surgically sterile
* Male subjects with WOCBP partners, dual contraception is required if no surgically sterile
Exclusion Criteria
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
* History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
* Have undergone major surgery within 3 months prior to screening.
* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
* History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
* Prior treatment with any oligonucleotides within 6 months if single dose or 12 months if multiple doses prior to screening.
* Exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening.
* With ANY of the abnormalities in clinical laboratory tests at screening and run-in period
* Clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening.
* Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilis infection
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Argo Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Markus Magerl, Doctor
Role: PRINCIPAL_INVESTIGATOR
Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie
Locations
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Institute for Asthma and Allergy - Wheaton
Silver Spring, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Duke University Medicine Center
Durham, North Carolina, United States
Penn State Milton S. Hershey MC - Penn State
Hershey, Pennsylvania, United States
Inova Clinical Trials and Research Center
Falls Church, Virginia, United States
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichaun, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Universitätsmedizin der Johannes Gutenberg
Mainz, Rhineland-Palatinate, Germany
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania, Catania, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Florence, Italy
Azienda Ospedale - Universita di Padova
Padua, PD, Italy
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Countries
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Central Contacts
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Facility Contacts
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Huamin Henry Li
Role: primary
H. Wedner
Role: primary
Patricia Luger
Role: primary
Rabahuddin Syed
Role: primary
Yuxiang Zhi
Role: primary
Chunrui Shi
Role: primary
Rongfei Zhu
Role: primary
YueMei Sun
Role: primary
Juan Meng
Role: primary
Yongmei Yu
Role: primary
Petra Staubach-Renz
Role: primary
Markus Magerl
Role: primary
Francesco Giardino
Role: primary
Alessandra Vultaggio
Role: primary
Riccardo Senter
Role: primary
Marcin Stobiecki
Role: primary
Stefan Cimbollek
Role: primary
Other Identifiers
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BW-20805-2001
Identifier Type: -
Identifier Source: org_study_id
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