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NCT04158934 · ClinicalTrials.gov registry record
A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
A clinical trial of Hemophilia A, sponsored by Baxalta now part of Shire.
- Active
- Registry status
- 207
- Enrollment target
- 20
- Study locations
NCT04158934: Active study of Hemophilia A, sponsored by Baxalta now part of Shire.
NCT04158934 is a study of Hemophilia A that is active but no longer recruiting, run by Baxalta now part of Shire. The registered enrollment target is 207 participants, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04158934, a study of Hemophilia A, is active but no longer recruiting, sponsored by Baxalta now part of Shire.
- ACTIVE NOT RECRUITING
- Registry status
- 207 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
Primary Outcome
An SAE is any untoward medical occurrence (whether considered to be related to study product or not) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event. An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical (study) product and th
Conditions Studied
Interventions
- BIOLOGICAL ADYNOVI/ADYNOVATE
Study Locations (20)
Other
- SHAT of Oncohaematology Diseases - Sofia
- Clinical Hospital Sveti Duh - Zagreb
- University hospital centre Zagreb - Zagreb
- University hospital centre Zagreb - Zagreb
- Fakultni nemocnice v Motole - Prague
- Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. - Ústí nad Labem
- Vivantes Klinikum im Friedrichshain - Berlin
- Universitaetsklinikum Bonn AoeR - Bonn
- Werlhof-Institut GmbH - Hanover
- Heim Pal Orszagos Gyermekgyogyaszati Intezet - Budapest
- Eszak-Pesti Centrumkorhaz - Honvedkorhaz - Budapest
- Debreceni Egyetem - Debrecen
- Mohacsi Korhaz - Mohács
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz - Nyíregyháza
- Pecsi Tudomanyegyetem Klinikai Kozpont - Pécs
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - Milan
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma
Florida
- UF Health Shands Hospital - Gainesville
Baden-Wurttemberg
- SRH Kurpfalzkrankenhaus Heidelberg GmbH - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2030-02-28 |
What the registry record for NCT04158934 still lists
NCT04158934 is an observational study that tracks outcomes without assigning an intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (138% higher).
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which ADYNOVI/ADYNOVATE is the first listed.
NCT04158934 names 20 study sites across 3 states, led by Other, Florida, Baden-Wurttemberg.
Frequently Asked Questions
What is clinical trial NCT04158934 about?
NCT04158934 is a clinical study titled "A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A". The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
What is the current status of trial NCT04158934?
This trial is currently active not recruiting. The enrollment target is 207 participants. The study started on 2020-07-09. Estimated completion is 2030-02-28.
What conditions does trial NCT04158934 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT04158934?
The interventions under investigation include: ADYNOVI/ADYNOVATE (BIOLOGICAL).
Who is sponsoring clinical trial NCT04158934?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04158934 being conducted?
This trial has 20 study locations across Florida, Baden-Wurttemberg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hemophilia A
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04158934's enrollment target sits among peer trials
207 5th of 42 higher than 38 of 42 other Hemophilia A trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia A trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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