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
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2022-08-03
2026-12-31
Brief Summary
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This study will evaluate the safety and preliminary efficacy of ASC618, an AAV vector encoding B-domain deleted codon-optimized human factor VIII under a synthetic liver-directed promoter
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ASC618
Experimental Arm
ASC618
ASC618 will be given as a single IV infusion
Interventions
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ASC618
ASC618 will be given as a single IV infusion
Eligibility Criteria
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Inclusion Criteria
* Severe or moderately severe hemophilia A (FVIII activity ≤ 2 IU/dL) as evidenced by
* medical history
* Received FVIII prophylactic or on-demand replacement therapy for ≥ 150 accumulated
* days (exposure days)
* ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
* BMI ≤ 30
* Agree to use double-barrier contraceptive until at least 3 consecutive semen samples are negative after ASC-618 infusion
Exclusion Criteria
* Current inhibitors, or history of high titer FVIII inhibitors
* Presence of \> Grade 2 liver fibrosis on elastography/Fibroscan or comparable imaging methodology
* History of chronic renal disease
* Active infection or any immunosuppressive disorder
* History of cardiac surgery and need anticoagulant therapy
* Any cardiovascular / genetic risk factors for thromboembolic disorders
* Evidence of active Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV)-1/2 or syphilis infection.
* Receipt of any vector or gene transfer agent
* Current antiviral therapy for hepatitis B or C
18 Years
MALE
No
Sponsors
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ASC Therapeutics
INDUSTRY
Responsible Party
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Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Other Identifiers
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ASC-HA-001
Identifier Type: -
Identifier Source: org_study_id
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