An observational study in Hemophilia A, sponsored by Baxalta now part of Shire. Active, not recruiting at 36 sites in 13 countries. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Baxalta now part of Shire (part of Takeda) · Observational
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.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's enrollment of 207 is above the median of 81 across 310 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Baxalta now part of Shire is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
First submitted after Baxalta became part of Takeda.
Counted across the registry records on this site, refreshed daily.
Up to 200 participants with haemophilia A will be enrolled. The study will be conducted in European, North American and Asian countries.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug page: BAX 855
Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.
Also known as: Antihaemophilic Factor [Recombinant] PEGylated rurioctocog alfa pegol, TAK-660, BAX 855
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events of Special Interest (AESI)
Adverse events of special interest are as follows: thromboembolic events, hypersensitivity reactions, lack of efficacy and confirmed FVIII inhibitor development.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Renal Function
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.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Hepatic Function
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.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Adverse Events (AE) Related to Impaired Neurologic Function
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.
Time frame: Throughout the study period (approximately up to 10 years)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Specified Time Points
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Change From Baseline in Alanine Aminotransferase (ALT) at Specified Time Points
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Change From Baseline in Bilirubin at Specified Time Points
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.
Time frame: 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
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.
Time frame: Baseline, Year 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Clinically significant abnormal findings in vital signs, collected as part of standard of care (SOC)/ standard clinical practice.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Physical Exam
Clinically significant abnormal findings in physical exam collected as part of standard of care (SOC)/ standard clinical practice.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Neurological Exam
Clinically significant abnormal findings in neurological exam collected as part of standard of care (SOC)/ standard clinical practice.
Time frame: Throughout the study period (approximately up to 10 years)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Clinically significant abnormal findings in clinical laboratory parameters collected as part of standard of care (SOC)/ standard clinical practice.
Time frame: Throughout the study period (approximately up to 10 years)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · vivli.org
Started Jul 2020 (actual). Primary completion is estimated for Feb 2030, 115 months after the start.
Of 53 industry-sponsored observational studies under Hemophilia A, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 79. This study's planned 115 months is above that.
Counting every sponsor, half of 131 studies reached it within 45 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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