MedTrace Logo

Study of a Gene Therapy Treatment for Hemophilia A

NCT06297486 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-12-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis.

Conditions

Interventions

GENETIC

SPK-8011

Participants will receive a single dose of SPK-8011, administered by intravenous (IV) infusion, on Day 1.

Sponsors & Collaborators

  • Spark Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2027-05-31
Completion
2035-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297486 on ClinicalTrials.gov