Phase 3 Haemophilia Trial, Recruiting NCT06922045 Sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd. Condition: Haemophilia
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Phase 3 Haemophilia Trial, Recruiting

NCT06922045
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 12 and 70 years old (inclusive)
  • You have been diagnosed with Hemophilia A or Hemophilia B
  • Your inhibitor levels have previously reached 5 BU or higher, and your inhibitor test is positive at the time of enrollment (confirm with trial site)
  • You are able to have a needle placed in a vein for treatment
  • You have had at least 3 bleeding episodes that needed treatment in the 6 months before your screening appointment
  • You agree to use reliable birth control to prevent pregnancy during the trial
  • You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

  • You have a blood clotting disorder other than Hemophilia
  • You plan to receive regular preventative clotting factor treatment during the trial
  • You plan to receive the medication Emicizumab during the trial
  • You have taken blood-thinning or clot-preventing medications in the 7 days before your first dose, or plan to take them during the trial
  • You have a history of blood clots in your arteries or veins
  • Your platelet count is below 100×10⁹/L (a measure of blood cells that help clotting) (confirm with trial site)
  • Your hemoglobin level (a measure of red blood cells) is below 90g/L (confirm with trial site)
  • You have serious liver or kidney disease
  • You had a severe bleeding episode within 4 weeks before your first dose
  • You had a major surgery or blood transfusion within 4 weeks before your first dose
  • You have a known allergy to the study drug STSP-0601
  • You are pregnant, breastfeeding, or have a positive pregnancy blood test
  • You have taken part in another clinical trial within 4 weeks before enrollment (though trials involving certain clotting factor products may be exceptions — confirm with trial site)
  • You have used certain clotting or related medications too recently before your first dose (the exact timeframes depend on the medication — confirm with trial site)
  • The trial doctors decide for any other reason that the trial is not appropriate for you

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lei Zhang, Ph.D, Hospital of Hematology, Chinese Academy of Medical Sciences

Phone: 010-67519614

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Jiangsu BioJeTay Biotechnology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
26 March 2025
Est. completion
1 September 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

12 hours effective hemostasis rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov