A Phase 3 interventional study of GS1191-0445 injection in Hemophilia A, sponsored by Gritgen Therapeutics Co., Ltd.. Recruiting at 13 sites in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Gritgen Therapeutics Co., Ltd. · Phase 3, Interventional, and Treatment
Among 93 studies in Hemophilia A with a site in China — 28 open to participants now, 39 under way, 19 of them phase 3. Hemophilia A · China.
Among the 93 studies in Hemophilia A with a site in China, this one is the 43rd largest by planned enrollment of the 80 interventional ones that give a count, is one of 5 that started in 2025, is one of 41 in phase 3, reaches primary completion later than 11 of the 38 other live ones, and was the 77th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →28 of the 93 studies in Hemophilia A with a site in China are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in China, United States, Argentina and 15 more countries
Ages 12+
Hoffmann-La Roche · Sites in China, United States, Argentina and 19 more countries
Ages 12+
Suzhou Alphamab Co., Ltd. · Sites in China
Ages 12–65 · Men only
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 12–65
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 12+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 86 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 30 (35%) stop at 75 or younger; 54 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
93 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 11 · Phase 3 43 · Phase 4 11
First in 2008; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.
Median enrollment 54 across the 80 interventional studies, 200 across the 13 observational. Of the 42 that completed or were terminated, 17 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
70 of 93 have an industry lead sponsor. The 10 most frequent:
Gritgen Therapeutics Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Gritgen Therapeutics Co., Ltd. has 2 studies filed under Hemophilia A — fewer than ten, so there is no comparison to draw.
14 of the studies in Hemophilia A with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06833983Phase 3Gritgen Therapeutics Co., Ltd.To Evaluate the Clinical Study of GS1191-0445 Injection in the Treatment of Hemophilia A | 2026-11-30 |
| NCT06136507Phase 3Jiangsu Gensciences lnc.Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A | 2026-12-31 |
| NCT04644575Phase 3Bioverativ, a Sanofi companyLong-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A | 2027-01-15 |
| NCT07663903Phase 3Hangzhou Gensciences Biopharmaceutical Co., Ltd.Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment | 2027-02 |
| NCT07684898Phase 3Hangzhou Gensciences Biopharmaceutical Co., Ltd.Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) as Prophylactic Treatment. | 2027-03-09 |
Add all 14 to your calendar (.ics) → With an account.
Among the 93 studies in Hemophilia A with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GS1191-0445 injection
A single intravenous administration of GS1191-0445 injection at a dose of 3E12 vg/kg
Annualized Bleeding Rate (ABR)
To evaluate the efficacy of a single intravenous administration of GS1191-0445 in subjects with hemophilia A
Time frame: Weeks 3 to 52 after infusion
Incidence of adverse events (AE)
The incidence of adverse events (AE) within 52 weeks after GS1191-0445 infusion, including serious adverse events (SAE) and adverse events of special concern (AESI)
Time frame: Within 52 weeks after infusion
Immunogenic response of AAV8 capsid protein and vector derived FVIII within 52 weeks after GS1191-0445 infusion
Evaluate the safety of a single intravenous infusion of GS1191-0445 injection in hemophilia A subjects
Time frame: Within 52 weeks after infusion
Evaluate the long-term efficacy of GS1191-0445 injection after intravenous infusion for 2-5 years
Evaluate the changes in annualized bleeding rate (ABR) and FVIII activity from baseline during the 2nd to 5th year after GS1191-0445 injection
Time frame: 2-5 years after infusion
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 19 months after the start.
Of 89 industry-sponsored phase 3 interventional studies under Hemophilia A, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 19 months is below that.
Counting every sponsor, half of 91 studies reached it within 33 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Gritgen Therapeutics Co., Ltd.