MedDataX Logo

A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

NCT ID: NCT04158934

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-09

Study Completion Date

2030-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ADVATE Post Authorization Safety Surveillance

NCT00214734

Hemophilia A
COMPLETED

ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

NCT02078427

Hemophilia A
COMPLETED

Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

NCT02634723

Hemophilia A
COMPLETED

Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures

NCT01913405

Hemophilia A
COMPLETED PHASE3

A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A

NCT05707351

Hemophilia A
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Haemophilia A Group

Participants with haemophilia A in the study will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national summary of product characteristics (SmPC).

ADYNOVI/ADYNOVATE

Intervention Type BIOLOGICAL

Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADYNOVI/ADYNOVATE

Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Antihaemophilic Factor [Recombinant] PEGylated rurioctocog alfa pegol TAK-660 BAX 855

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
* Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
* Negative factor VIII (FVIII) inhibitor test at study entry.
* Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.

Exclusion Criteria

* Previous participation in this study. Participation is defined as signed informed consent.
* Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
* Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baxalta now part of Shire

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UF Health Shands Hospital

Gainesville, Florida, United States

Site Status

SHAT of Oncohaematology Diseases

Sofia, , Bulgaria

Site Status

Clinical Hospital Sveti Duh

Zagreb, , Croatia

Site Status

University hospital centre Zagreb

Zagreb, , Croatia

Site Status

University hospital centre Zagreb

Zagreb, , Croatia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

Ústí nad Labem, , Czechia

Site Status

SRH Kurpfalzkrankenhaus Heidelberg GmbH

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status

Universitaetsklinikum Bonn AoeR

Bonn, , Germany

Site Status

Werlhof-Institut GmbH

Hanover, , Germany

Site Status

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, , Hungary

Site Status

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Site Status

Debreceni Egyetem

Debrecen, , Hungary

Site Status

Mohacsi Korhaz

Mohács, , Hungary

Site Status

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Site Status

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Site Status

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Site Status

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Roma, , Italy

Site Status

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

University Medical Centre Groningen-UMCG

Groningen, , Netherlands

Site Status

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Ulsan University Hospital

Ulsan, , South Korea

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

MacKay Memorial Hospital_Tamsui Branch

Taipei, , Taiwan

Site Status

Tri-Service General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital, Linkou

Taoyuan District, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Phramongkutklao Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkoknoi Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Bulgaria Croatia Czechia Germany Hungary Italy Netherlands South Korea Spain Sweden Taiwan Thailand

Related Links

Access external resources that provide additional context or updates about the study.

https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48ce6

To obtain more information on the study, click here/on this link

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EUPAS35698

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-660-403

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BAX 855 Continuation
NCT01945593 COMPLETED PHASE3
Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A
NCT02035384 COMPLETED
Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
NCT00243386 COMPLETED PHASE4
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
NCT01395810 COMPLETED PHASE3
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
NCT02256917 COMPLETED PHASE3
PF-06741086 Long-term Treatment in Severe Hemophilia
NCT03363321 COMPLETED PHASE2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
NCT05987449 RECRUITING PHASE1/PHASE2
Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
NCT00323856 COMPLETED PHASE4
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
NCT01562158 COMPLETED PHASE2
Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
NCT03938792 COMPLETED PHASE3
Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
NCT01405742 TERMINATED PHASE3
A Study of ADVATE in People With Hemophilia A in India
NCT04985682 COMPLETED PHASE4
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
NCT03695978 RECRUITING
Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
NCT02830477 COMPLETED
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
NCT05568719 RECRUITING PHASE3
A Study in Children, Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate
NCT04876365 COMPLETED
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
NCT00289536 COMPLETED PHASE4
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
NCT01736475 COMPLETED PHASE2/PHASE3
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
NCT01233258 COMPLETED PHASE3
ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)
NCT02093741 COMPLETED
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
NCT01561391 COMPLETED PHASE4
A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)
NCT03587116 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of Valoctocogene Roxaparvovec, With Prophylactic Steroids in Hemophilia A
NCT04323098 COMPLETED PHASE3
Study Evaluating ReFacto AF in Severe Hemophilia A
NCT00037544 COMPLETED PHASE3
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
NCT00141843 COMPLETED PHASE3