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Virus Therapy
Gene Therapy for Hemophilia A (GO-8 Trial)
Phase 1 & 2
Recruiting
Led By Pratima Chowdary, MD
Research Sponsored by University College, London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult males, ≥ 18 years of age with confirmed diagnosis of severe HA resulting from gene mutations that have a low risk for inhibitor development
Severe bleeding phenotype as defined by prophylaxis for a history of bleeding or on demand therapy with a current or past history of 4 or more bleeding episodes/year or evidence of chronic haemophilic arthropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annual review for 5 years
Awards & highlights
GO-8 Trial Summary
This trial is testing a new gene therapy for people with severe hemophilia A. They want to see if it is safe and works well.
Who is the study for?
Adult males over 18 with severe Hemophilia A, who have used hFVIII concentrates for more than 50 days and suffer from frequent bleeding or joint damage due to bleeding. Participants must be able to follow the trial procedures for five years and use barrier contraception post-treatment until semen tests confirm safety.Check my eligibility
What is being tested?
The GO-8 study is testing a gene therapy called AAV2/8-HLP-FVIII-V3 in men with severe Hemophilia A. It aims to evaluate how safe and effective this treatment is over time.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the body's immune response against the new gene or the viral vector used, liver dysfunction, increased risk of blood clots, or other unforeseen complications.
GO-8 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man over 18 with severe hemophilia A due to low-risk gene mutations.
Select...
I have a severe bleeding disorder with frequent bleeding episodes or joint damage due to bleeding.
Select...
I have been treated with hFVIII for over 50 days.
GO-8 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ annual review for 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annual review for 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety - Dose Limiting Toxicity possibly attributable to the gene therapy
Safety - Neutralising anti-hFVIII antibody development following gene therapy
Secondary outcome measures
Bleeding frequency
Immune response to the AAV8 capsid.
Plasma hFVIII activity
+2 moreGO-8 Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Treatment with AAV2/8-HLP-FVIII-V3
Find a Location
Who is running the clinical trial?
University College, LondonLead Sponsor
834 Previous Clinical Trials
38,910,381 Total Patients Enrolled
4 Trials studying Hemophilia A
77 Patients Enrolled for Hemophilia A
Medical Research CouncilOTHER_GOV
315 Previous Clinical Trials
1,962,879 Total Patients Enrolled
Pratima Chowdary, MDPrincipal InvestigatorRoyal Free London NHS Foundation Trust
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests show higher than normal levels.I am a man over 18 with severe hemophilia A due to low-risk gene mutations.I have a severe bleeding disorder with frequent bleeding episodes or joint damage due to bleeding.I have been treated with hFVIII for over 50 days.My health limits my daily activities significantly.I have severe haemophilia A with specific genetic changes.You have used an experimental treatment for hemophilia within the past month.I do not have uncontrolled heart failure or unstable chest pain.I have had tuberculosis, fungal disease, or another long-term infection.I do not have uncontrolled glaucoma, diabetes, or high blood pressure.My liver ultrasound showed a possible cancer sign.I have a history of blood clots or conditions like atrial fibrillation.My doctor agrees I can follow the study's requirements.I have not received any gene therapy in the last 6 months.I have active hepatitis B or C, or I am on antiviral therapy for it.You have a score of 2 or higher on the CHA2DS2-VASc scale, which means you have a higher risk of stroke.My recent CT scan shows lung lesions that may be cancerous.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please state how many individuals are taking part in this experiment?
"The most recent update on clinicaltrials.gov was on March 11th, 2020, which indicates that the study is actively recruiting 18 patients from 2 sites."
Answered by AI
Does the FDA recognize AAV2/8-HLP-FVIII-V3 as a safe and effective treatment?
"AAV2/8-HLP-FVIII-V3 is still in early stages of development, so it received a score of 1."
Answered by AI
Are new participants currently being accepted for this research study?
"Yes, this is an active recruitment according to the most recent update on clinicaltrials.gov. This particular study was posted on 6/14/2017 and updated as recently as 3/11/2020. They are looking for a total of 18 participants that will be drawn from 2 different sites."
Answered by AI
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