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

February 13, 2026 updated by: Baxalta now part of Shire

Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1527
        • SHAT of Oncohaematology Diseases
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Sveti Duh
      • Zagreb, Croatia, 1000
        • University Hospital Centre Zagreb
  • Czechia
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
      • Ústí nad Labem, Czechia, 40113
        • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
  • Germany
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
      • Bonn, Germany, 53127
        • Universitaetsklinikum Bonn AoeR
      • Hanover, Germany, 30159
        • Werlhof-Institut GmbH
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, D-69123
        • SRH Kurpfalzkrankenhaus Heidelberg GmbH
  • Hungary
      • Budapest, Hungary, 1134
        • Észak-Pesti Centrumkórház - Honvédkórház
      • Budapest, Hungary, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem
      • Mohács, Hungary, 7700
        • Mohacsi Korhaz
      • Nyíregyháza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
      • Pécs, Hungary, 7624
        • Pécsi Tudományegyetem Klinikai Központ
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Roma, Italy, 00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Centre Groningen-UMCG
  • South Korea
      • Seoul, South Korea, 134-727
        • Kyung Hee University Hospital at Gangdong
      • Ulsan, South Korea, 44033
        • Ulsan University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrín
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Málaga
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07120
        • Hospital Universitari Son Espases
  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska Universitetssjukhuset
  • Taiwan
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 10449
        • MacKay Memorial Hospital_Taipei Branch
      • Taoyuan District, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkoknoi Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health Shands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 200 participants with haemophilia A will be enrolled. The study will be conducted in European, North American and Asian countries.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Biological: ADYNOVI/ADYNOVATE
Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.
Other Names:
  • BAX 855
  • TAK-660
  • Antihaemophilic Factor [Recombinant] PEGylated rurioctocog alfa pegol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: Throughout the study period (approximately up to 10 years)
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 that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (study) product, whether or not related to the medicinal (study) product. AEs and SAEs that are at least possibly related to study drug ADYNOVI/ADYNOVATE will be evaluated in this outcome.
Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events of Special Interest (AESI)
Time Frame: Throughout the study period (approximately up to 10 years)
Adverse events of special interest are as follows: thromboembolic events, hypersensitivity reactions, lack of efficacy and confirmed FVIII inhibitor development.
Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Renal Function
Time Frame: Throughout the study period (approximately up to 10 years)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical (study) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (study) product, whether or not related to the medicinal (study) product. AEs (at least possibly related) that are potentially indicative of or related to long-term effects of PEG accumulation impaired renal function will be evaluated in this outcome.
Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Hepatic Function
Time Frame: Throughout the study period (approximately up to 10 years)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical (study) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (study) product, whether or not related to the medicinal (study) product. AEs (at least possibly related) that are potentially indicative of or related to long-term effects of PEG accumulation impaired hepatic function will be evaluated in this outcome.
Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Neurologic Function
Time Frame: Throughout the study period (approximately up to 10 years)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical (study) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (study) product, whether or not related to the medicinal (study) product. AEs (at least possibly related) that are potentially indicative of or related to long-term effects of PEG accumulation impaired neurologic function will be evaluated in this outcome.
Throughout the study period (approximately up to 10 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Specified Time Points
Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
eGFR levels will be assessed from baseline to end of the study at every visit. Note: all assessments are being done as per Standard of Care (SOC) at each study site/ center and are not mandatory.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Change From Baseline in Alanine Aminotransferase (ALT) at Specified Time Points
Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
ALT levels will be assessed from baseline to end of the study at every visit. Note: all assessments are being done as per Standard of Care (SOC) at each study site/ center and are not mandatory.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Change From Baseline in Bilirubin at Specified Time Points
Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Bilirubin levels will be assessed from baseline to end of the study at every visit. Note: all assessments are being done as per Standard of Care (SOC) at each study site/ center and are not mandatory.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Change From Baseline in Polyethylene Glycol (PEG) Plasma Levels at Specified Time Points
Time Frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
PEG plasma levels will be assessed from baseline to end of the study at every visit. Note: all assessments are being done as per Standard of Care (SOC) at each study site/ center and are not mandatory.
Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time Frame: Throughout the study period (approximately up to 10 years)
Clinically significant abnormal findings in vital signs, collected as part of standard of care (SOC)/ standard clinical practice.
Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Physical Exam
Time Frame: Throughout the study period (approximately up to 10 years)
Clinically significant abnormal findings in physical exam collected as part of standard of care (SOC)/ standard clinical practice.
Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Neurological Exam
Time Frame: Throughout the study period (approximately up to 10 years)
Clinically significant abnormal findings in neurological exam collected as part of standard of care (SOC)/ standard clinical practice.
Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Time Frame: Throughout the study period (approximately up to 10 years)
Clinically significant abnormal findings in clinical laboratory parameters collected as part of standard of care (SOC)/ standard clinical practice.
Throughout the study period (approximately up to 10 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxalta now part of Shire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-660-403
  • EUPAS35698 (Registry Identifier: EUPAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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