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A Gene Transfer Study for Hemophilia A

NCT03003533 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-12-30

Study results available
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Summary

This clinical research study is being conducted by Spark Therapeutics, Inc. to determine the safety and efficacy of the factor VIII gene transfer treatment with SPK-8011 in individuals with hemophilia A.

Conditions

Interventions

GENETIC

SPK-8011

A novel, bio-engineered, recombinant adeno-associated viral vector carrying human factor VIII gene

Sponsors & Collaborators

  • Spark Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Director · Spark Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2023-12-05
Completion
2023-12-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • Thailand

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 NCT03003533 on ClinicalTrials.gov