Phase 1 Haemophilia Trial, Recruiting NCT03961243 Sponsor: Shenzhen Geno-Immune Medical Institute Condition: Haemophilia
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Phase 1 Haemophilia Trial, Recruiting

NCT03961243
Recruiting Phase 1

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:

  • People who are able to give informed consent and follow the study requirements
  • Males aged 2 years or older who have a confirmed diagnosis of hemophilia B, with factor IX levels at or below 2% of normal
  • People who have had an average of at least 4 bleeding episodes per year that required treatment with factor IX infusions, either on-demand or as a regular preventative treatment
  • People who have no detectable factor IX inhibitors (antibodies that block factor IX) based on central laboratory testing, and no previous history of such inhibitors
  • People who agree to use reliable barrier contraception until 3 consecutive tests show no trace of the study vector in their system

Who may not be able to join:

  • People with significant liver problems, including abnormal levels of certain liver markers (alanine transaminase, bilirubin, or alkaline phosphatase)
  • People with a history of inhibitors (antibodies) against factor IX
  • People with active hepatitis B or C who are currently receiving antiviral treatment
  • People with HIV-1 or HIV-2 whose immune cell (CD4) count is at or below 200/mm³ — note that people who are HIV-positive but stable, with a CD4 count above 200/mm³ and an undetectable viral load, may still be considered eligible (confirm with trial site)
  • People with any active infection or any condition that weakens the immune system
  • People who have taken part in a gene therapy trial within the past 6 months, or in any clinical trial involving an experimental drug within the past 12 weeks
  • People who are unable or unwilling to follow the study assessments and requirements

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 27 July 2026
Phase 1: approximately ~10% 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: Lung-Ji Chang, PhD, Shenzhen Geno-Immune Medical Institute

Phone: +86 0755-86573763

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 1
Sponsor
Shenzhen Geno-Immune Medical Institute
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
31 May 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants experiencing drug-related adverse events

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: 27 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