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NCT03876301 · ClinicalTrials.gov registry record

Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants

A clinical trial, sponsored by Spark Therapeutics.

Completed
Registry status
25
Enrollment target

NCT03876301 is a clinical trial that has completed, run by Spark Therapeutics. The registered enrollment target is 25 participants.

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The verdict

NCT03876301 has completed, sponsored by Spark Therapeutics.

COMPLETED
Registry status
25 participants
Enrollment target

Study Summary

The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of care. The data collected from this study may assist in providing baseline information for comparison to the Spark's investigational hemophilia A gene therapy in future Phase 3 studies.

Interventions

  • DRUG Standard of Care FVIII Replacement therapy

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-01-21
Est. Completion 2023-05-02

Sponsor

Spark Therapeutics

13 total trials

What the Registry Record Tells You About NCT03876301

The ClinicalTrials.gov registry entry for NCT03876301 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spark Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Standard of Care FVIII Replacement therapy is the first listed.

NCT03876301 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03876301 about?

NCT03876301 is a clinical study titled "Lead-in Study to Collect Prospective Efficacy and Safety Data of Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Participants". The aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and FVIII infusions, in patients with clinically severe hemophilia A receiving prophylactic FVIII replacement therapy as standard of car...

What is the current status of trial NCT03876301?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2019-01-21. Estimated completion is 2023-05-02.

What interventions are being tested in trial NCT03876301?

The interventions under investigation include: Standard of Care FVIII Replacement therapy (DRUG).

Who is sponsoring clinical trial NCT03876301?

This trial is sponsored by Spark Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.