NCT04560933

Brief Summary

To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

3.1 years

First QC Date

September 15, 2020

Last Update Submit

April 22, 2024

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

  • Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A

    To assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A at Baseline

    Baseline

  • Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A

    Change from baseline through Week 12

Secondary Outcomes (2)

  • To describe and characterize AAV vector titer values in subjects with Hemophilia A

    Change from baseline through Week 12

  • To describe and characterize AAV vector titer values in subjects with Hemophilia A

    Change from baseline through Week 24

Interventions

Blood sample collectionPROCEDURE

Blood sample collection

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects diagnosed with Hemophilia A

You may qualify if:

  • Subjects diagnosed with Hemophilia A
  • Subjects aged 18years or over at time of entry

You may not qualify if:

  • Currently participating in an interventional study of any investigational product, device or procedure.
  • Subjects who have been previously treated with AAV vector gene therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Inc

Madison, Wisconsin, 53704, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample collection for AAVx serotypes

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Stephen Flach, MD

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 23, 2020

Study Start

August 25, 2020

Primary Completion

September 20, 2023

Study Completion

October 20, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)