To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A
ConditionHemophilia A
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-65
SponsorGritgen Therapeutics Co., Ltd.
About this trial
This study is a single-arm, open-label, multicenter study evaluating the efficacy and safety of GS1191-0445 injection as a single dose in Chinese subjects with hemophilia A.
GS1191-0445 is an AAV8-based gene therapy vector designed to express B-domain deleted human factor VIII (FVIII) under the regulation of a human liver-specific promoter. Following a single intravenous administration, AAV8 targets hepatocytes and facilitates the specific expression and secretion of FVIII into the bloodstream.
Eligibility criteria
Qualifiers
Participants with confirmed hemophilia A in their pre-admission history and based on clinical laboratory examination ;
Subjects had used FVIII products for at least 150 exposure days (ED) before enrollment;
Subject has no prior history of FVIII inhibitors;
Subjects agree to use a reliable barrier contraceptive method from the date of signing the informed consent
Disqualifiers
The subject has any hemorrhagic disorder not related to hemophilia A,
Abnormal liver function test results of subjects during screening.
Abnormal laboratory examination of subjects during screening
The subject has acute or chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Or are receiving antiviral treatment for hepatitis B and C;
Trial design
Treatments tested in this trial
- GS1191-0445 injection
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov