Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding (HA-SAFE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04461639 |
Recruitment Status :
Active, not recruiting
First Posted : July 8, 2020
Last Update Posted : April 12, 2024
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Condition or disease | Intervention/treatment |
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Hemophilia A | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027) |
Study Type : | Observational |
Actual Enrollment : | 62 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A |
Actual Study Start Date : | May 14, 2021 |
Estimated Primary Completion Date : | June 30, 2028 |
Estimated Study Completion Date : | June 30, 2028 |
Group/Cohort | Intervention/treatment |
---|---|
Damoctocog alfa pegol
Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.
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Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice |
- Number of participants with safety events [ Time Frame: At least 4 years ]
- Duration of safety events [ Time Frame: At least 4 years ]
- Number of participants with safety events leading to a change of treatment [ Time Frame: At least 4 years ]
- Number of participants with safety events per intensity [ Time Frame: At least 4 years ]The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe
- Number of participants with safety events with outcome of death [ Time Frame: At least 4 years ]
- Number of participants with safety events related to inhibitor development [ Time Frame: At least 4 years ]
- Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders [ Time Frame: At least 4 years ]
- Number of adverse reactions (ARs) related to hepatic or renal function [ Time Frame: At least 4 years ]
- Change from baseline in creatinine [ Time Frame: At least 4 years ]
- Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: At least 4 years ]
- Change from baseline in alanine transaminase (ALT) [ Time Frame: At least 4 years ]
- Change from baseline in aspartate aminotransferase (AST) [ Time Frame: At least 4 years ]
- Change from baseline in bilirubin [ Time Frame: At least 4 years ]
- Testing for PEG plasma levels (baseline and end of study) [ Time Frame: At least 4 years ]PEG (Polyethylene Glycol)-plasma levels at baseline and end of study will be analyzed only if PEG-plasma levels were collected in local routine clinical practice at the investigator's discretion.
- Number of patients with abnormal findings as assessed by neurological examination [ Time Frame: At least 4 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Signed informed consent/assent will be obtained before any study-related activities
- PTPs with hemophilia A assigned to Jivi prophylaxis treatment
- Negative FVIII inhibitor test before study entry
- Decision to initiate treatment with commercially available Jivi has been made by the treating physician before and independently from the decision to include the patient in this study
Exclusion Criteria:
- Known or suspected contraindications to Jivi or related products
- Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation
- Participation in an investigational program with interventions outside of routine clinical practice
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461639
Austria | |
Many Locations | |
Multiple Locations, Austria | |
Germany | |
Many Locations | |
Multiple Locations, Germany | |
Greece | |
Many Locations | |
Multiple Locations, Greece | |
Italy | |
Many Locations | |
Multiple Locations, Italy | |
Slovenia | |
Many Locations | |
Multiple Locations, Slovenia | |
Spain | |
Many Locations | |
Multiple Locations, Spain |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT04461639 |
Other Study ID Numbers: |
20904 |
First Posted: | July 8, 2020 Key Record Dates |
Last Update Posted: | April 12, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Factor VIII Coagulants |