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In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study.
Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery.
The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments.
Through this study, researchers want to learn more about its safety in a real-world setting.
The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information.
The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment.
Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-marketing surveillance cohort | Participants follow their usual medical visits with data collection occurs continuously in a 36-week observational period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damoctocog-alfa-pegol (Jivi, BAY94-9027) | Drug | Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events (AEs) | Number of participants with AEs | Up to 36 weeks |
| Occurrence of Serious adverse events (SAEs) | Number of participants with SAEs | Up to 36 weeks |
| Occurrence of adverse reactions (ARs) | Number of participants with ARs | Up to 36 weeks |
| Occurrence of Serious adverse reactions (SARs) | Number of participants with SARs | Up to 36 weeks |
| Occurrence of adverse events of important identified risks (AESIs) | Important identified risks include development of Factor VIII inhibitors/Hypersensitivity/Clinical response characterised by lack of drug effect associated with anti-polyehtylene glycol (PEG) antibodies. | Up to 36 weeks |
| Number of adverse events related to overdose | Up to 36 weeks | |
| Number of adverse events related to previously taken drugs and concomitant drugs | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized number of reported total bleeds | Up to 36 weeks | |
| Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol) | Up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The study should be conduct on hemophilia A patients who are prescribed with Jivi (damoctocog alfa pegol) as sole treatment for an approved indication (the treatment and prophylaxis of bleeding in PTPs aged ≥ 12 years with hemophilia A (congenital FVIII deficiency)) by the Ministry of Food and Drug Safety (MFDS) in Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Recruiting | Multiple Locations | South Korea |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Difference annualized total/average factor consumption (for overall, prophylaxis, bleeds(Intermittent prophylaxis), and other events) from previous FVIII products versus Jivi (damoctocog alfa pegol) | Up to 36 months |
| Regimen selection determinants (physician and patient) | Up to 36 weeks |
| Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment | Up to 36 weeks |
| ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study | ABR stands for annualized bleeding rate. | Up to 36 weeks |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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