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ASC618 Gene Therapy for Hemophilia A

This study is testing a new gene therapy called ASC618 for people with hemophilia A. Hemophilia A is a bleeding disorder where your blood doesn't clot properly. Currently, people with hemophilia A need frequent injections to manage their condition. ASC618 is given as a single intravenous (IV) infusion, meaning it's put directly into your vein. The study aims to see how safe ASC618 is and if it helps improve your condition. Researchers will be looking for any side effects or serious side effects for 12 months after you receive the infusion. To join, you must be a man at least 18 years old with severe or moderately severe hemophilia A. The study plans to enroll 12 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 male participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after receiving the infusion to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04676048

ASC618 Gene Therapy in Hemophilia A Patients

Recruiting
PHASE1Ages 18+InterventionalTreatment
ASC Therapeutics
~12 participants
Updated 2023-02-01 on ClinicalTrials.gov
What's tested:ASC618

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events, and serious AEs
Measured over 12 months post-infusion

Conditions

Hemophilia A

Explore related trials

Hemophilia A

Where it's being run

1 sites across 1 states
Arkansas1

Who to contact

Clinical Trial Manager, PhD
[email protected]
(408) 495-3891
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male ≥18 years of age
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

Pre-existing immunity to AAV8 vector as defined by AAV8 total antibodies and neutralizing antibodies qualified tests.
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

What this trial measures

  • Number of adverse events, and serious AEs12 months post-infusion