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Gene Therapy

Gene Therapy for Hemophilia A

Q: Which hospitals are conducting this research?

This clinical trial is actively recruiting patients at 21 different locations, including UC Davis Ambulatory Care Clinic in Sacramento, Midtown Ambulatory Care Center in Little Rock, <a href="https://www.withpower.com/clinical-trials/arkansas">Arkansas</a> Children's Hospital in Miami, and other sites.

Q: Does this research project explore new territory in the medical field?

SB-525 (PF-07055480) was first studied in 2017 by Pfizer. A Phase 2 drug approval followed the initial trial, which only involved 11 patients. Now, there are 16 countries and 21 cities with active trials for SB-525 (PF-07055480).

Q: Could you please tell me what other research has been conducted on SB-525 (PF-07055480)?

At this moment in time, there are two ongoing clinical trials involving SB-525 (PF-07055480), with one of them being in Phase 3. Even though a few of the studies related to SB-525 (PF-07055480) are based in Seattle, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>, 57 different locations across America are running trials for it.

Q: Are people being recruited for this clinical trial right now?

According to the latest information from clinicaltrials.gov, this trial is not currently looking for patients. Although the study was last updated on September 19th, 2022, it is no longer recruiting participants. There are, however, 93 other trials that are still actively searching for patients.

Q: Has SB-525 (PF-07055480) been linked with any adverse health effects in patients?

While there is some data supporting SB-525's (PF-07055480) safety, as this is a Phase 2 trial, none of the available information suggests that it is an effective medication.

Q: How many subjects are included in this clinical trial?

Recruitment for this clinical trial has closed. The study was originally posted on June 21st, 2017 and updated September 19th, 2022. For those still looking to participate in active trials, there are 91 studies currently underway for patients with hemophilia A and 2 more for SB-525 (PF-07055480).

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe hemophilia A (past evidence of circulating FVIII activity of < 1% normal)

Male ≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after sb-525 (pf-07055480) infusion

Awards & highlights

Study Summary

This trial is testing a new drug to treat hemophilia A. They are testing how safe and tolerated it is, and how long it lasts in the body.

Who is the study for?

This trial is for men over 18 with severe Hemophilia A, who have had at least 150 days of prior treatment and experienced a minimum of 12 bleeding episodes in the last year. Participants must use double barrier contraception post-treatment until tests confirm no gene therapy vectors in semen.Check my eligibility

What is being tested?

The study is testing SB-525 (PF-07055480), a gene therapy aiming to correct factor VIII deficiency in Hemophilia A patients. It will assess how safe it is, how well people tolerate it, and track the activity level of factor VIII after dosing.See study design

What are the potential side effects?

Potential side effects may include immune reactions to the introduced vector or Factor VIII, liver inflammation or damage due to viral vector delivery system used by SB-525, and general symptoms like fatigue or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe hemophilia A with very low FVIII activity.

Select...

I am a man aged 18 or older.

Select...

I agree to use two forms of birth control until my tests show no AAV 2/6 after treatment.

Select...

I have been treated with FVIII or cryoprecipitate for over 150 days.

Select...

I've had 12 or more bleeding episodes in the last year while on on-demand therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years after sb-525 (pf-07055480) infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years after sb-525 (pf-07055480) infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years after sb-525 (pf-07055480) infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in circulating FVIII activity

Incidence of adverse events and serious adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential dose escalationExperimental Treatment1 Intervention

SB-525 (PF-07055480) is administered as a single infusion

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,863 Total Patients Enrolled

43 Trials studying Hemophilia A

6,204 Patients Enrolled for Hemophilia A

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,031 Total Patients Enrolled

42 Trials studying Hemophilia A

2,945 Patients Enrolled for Hemophilia A

Media Library

SB-525 (PF-07055480) (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03061201 — Phase 2

Hemophilia A Research Study Groups: Sequential dose escalation

Hemophilia A Clinical Trial 2023: SB-525 (PF-07055480) Highlights & Side Effects. Trial Name: NCT03061201 — Phase 2

SB-525 (PF-07055480) (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03061201 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which hospitals are conducting this research?

"This clinical trial is actively recruiting patients at 21 different locations, including UC Davis Ambulatory Care Clinic in Sacramento, Midtown Ambulatory Care Center in Little Rock, Arkansas Children's Hospital in Miami, and other sites."

Answered by AI

Does this research project explore new territory in the medical field?

"SB-525 (PF-07055480) was first studied in 2017 by Pfizer. A Phase 2 drug approval followed the initial trial, which only involved 11 patients. Now, there are 16 countries and 21 cities with active trials for SB-525 (PF-07055480)."

Answered by AI

Could you please tell me what other research has been conducted on SB-525 (PF-07055480)?

"At this moment in time, there are two ongoing clinical trials involving SB-525 (PF-07055480), with one of them being in Phase 3. Even though a few of the studies related to SB-525 (PF-07055480) are based in Seattle, Washington, 57 different locations across America are running trials for it."

Answered by AI

Are people being recruited for this clinical trial right now?

"According to the latest information from clinicaltrials.gov, this trial is not currently looking for patients. Although the study was last updated on September 19th, 2022, it is no longer recruiting participants. There are, however, 93 other trials that are still actively searching for patients."

Answered by AI

Has SB-525 (PF-07055480) been linked with any adverse health effects in patients?

"While there is some data supporting SB-525's (PF-07055480) safety, as this is a Phase 2 trial, none of the available information suggests that it is an effective medication."

Answered by AI

How many subjects are included in this clinical trial?

"Recruitment for this clinical trial has closed. The study was originally posted on June 21st, 2017 and updated September 19th, 2022. For those still looking to participate in active trials, there are 91 studies currently underway for patients with hemophilia A and 2 more for SB-525 (PF-07055480)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A

2017. "A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03061201.

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