A Phase 1/2 interventional study of GS1191-0445 injection in Severe Hemophilia A, sponsored by Gritgen Therapeutics Co., Ltd.. Active, not recruiting at 2 sites in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Gritgen Therapeutics Co., Ltd. · Phase 1/2, 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 76th largest by enrollment of the 80 interventional ones that give a count, is one of 10 that started in 2023, is one of 5 in phase 1/2, reaches primary completion later than 0 of the 38 other live ones, and was the 85th 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. 10 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below 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 study evaluating the safety and efficacy of GS1191-0445 injection as a single dose in Chinese subjects with severe hemophilia A.
GS1191-0445 is an adeno-associated virus 8 (AAV8)-delivered gene therapy 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 gene expression cassette, which transfects hepatocytes and facilitates the specific expression and secretion of FVIII into the blood.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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
Number of participants with Adverse Events (AE) as assessed by CTCAE v5.0, including Adverse Event of Special Interests (AESI) and Serious Adverse Events (SAE);
Time frame: Five years after infusion
Number of Participants with Thrombosis Risk: In subjects with >150% FⅧ:C post-GS1191-0445 infusion, VTE risk will be assessed via Caprini model, coagulation function, D-dimer, FDP, and TAT;
Time frame: Five years after infusion
The shedding of GS1191-0445 viral vector: Viral vector titers in serum, saliva, urine, semen and fecal will be monitored;
Time frame: Five years after infusion
Total FⅧ Antibody Levels: Total FⅧ antibody levels will be measured to determine the immunogenicity of FⅧ expression protein;
Time frame: Five years after infusion
FVIII inhibitor: Factor Ⅷ inhibitor will be measured to determine the immunogenicity of FⅧ expression protein;
Time frame: Five years after infusion
The number of dose-limiting toxicity (DLT) events will be determined by the Safety Review Committee (SRC), at least 12 weeks after GS1191-0445 infusion.
Time frame: Five years after infusion
The Change of Laboratory Values: Change in serum chemistry values including liver function tests, hematology, and urinalysis;
Time frame: Five years after infusion
Changes for vital signs: Includes sitting blood pressure (mmHg), respiratory rate (breaths/min), body temperature (°C), and pulse rate (beats/min);
Time frame: Five years after infusion
Changes for physical examination: Includes skin, mucous membranes, lymph nodes, head and neck, chest (heart, lungs), abdomen, muscles, nervous system, spine/extremities;
Time frame: Five years after infusion
The immunogenicity of AAV capsid protein: Collection of Peripheral Blood Mononuclear Cell (PBMC) and serum samples for vector shedding detection;
Time frame: Five years after infusion
Vector-derived FⅧ Activity Level: Validated methods will be used to measure vector-derived FⅧ activity, including peak and steady state following GS1191-0445 infusion；
Time frame: Day 4 to Week 52 after infusion
Total Consumption of Exogenous FⅧ Infusion;
Time frame: Weeks 3 to 52 and five years after infusion
Annualized Consumption of FⅧ Infusion；
Time frame: Weeks 3 to 52 and five years after infusion
Number of bleeding events requiring exogenous FⅧ infusion: To assess the number of bleeding events requiring exogenous FⅧ infusion after administration;
Time frame: Weeks 3 to 52 and five years after infusion
Number of bleeding events: To assess bleeding events, including spontaneous, traumatic and untreated bleeding events after administration
Time frame: Weeks 3 to 52 and five years after infusion
Number of joint bleeding events: To assess joint bleeding events after administration
Time frame: Weeks 3 to 52 and five years after infusion
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Dec 2024, 17 months.
Of 20 phase 1/2 interventional studies under Hemophilia A, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gritgen Therapeutics Co., Ltd.