Phase 1 Haemophilia Trial, Recruiting NCT03217032 Sponsor: Shenzhen Geno-Immune Medical Institute Condition: Haemophilia
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Phase 1 Haemophilia Trial, Recruiting

NCT03217032
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:

  • You are able to give your agreement to take part and are willing to follow the study's requirements
  • You are male, aged 2 years or older, and have been confirmed to have hemophilia A with very low levels of factor VIII (2% or less of the normal amount)
  • You have had an average of at least 4 bleeding episodes per year that needed treatment with factor VIII infusions, either as needed or on a regular schedule
  • You have no detectable antibodies (called inhibitors) against factor VIII, confirmed by a lab test, and have never had a history of these inhibitors
  • You agree to use reliable barrier contraception (such as condoms) until 3 consecutive tests show no trace of the study's gene vector in your body

Who may not be able to join:

  • You have significant liver problems, shown by abnormal results on certain liver blood tests (alanine transaminase, bilirubin, and alkaline phosphatase)
  • You have a history of developing inhibitors (antibodies) against factor VIII
  • You currently have active hepatitis B or C and are receiving antiviral treatment for it
  • You have HIV-1 or HIV-2 with a low immune cell count (CD4 count at or below 200/mm³) — note: people with HIV who are stable, with a CD4 count above 200/mm³ and an undetectable viral load, may still be eligible (confirm with trial site)
  • You have any signs of an active infection or a condition that weakens your immune system
  • You have taken part in a gene therapy trial in the last 6 months, or any other trial involving an experimental drug in the last 12 weeks
  • You are unwilling or unable to take part in the study's required assessments and visits

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 26 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, 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: 26 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