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)

• ClinicalTrials.gov Identifier: NCT04461639
• Recruitment Status: Active, not recruiting
• First Posted: July 8, 2020
• Last Update Posted: May 16, 2024
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: June 18, 2020
• First Posted Date: July 8, 2020
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: May 14, 2021
• Estimated Primary Completion Date: June 30, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 2, 2020)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 2, 2020)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
• Brief Summary: In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All previously treated patients (PTPs) with hemophilia A receiving prophylaxis with damoctocog alfa pegol will be eligible to be enrolled in the study. Indications and contra-indications according to the local market authorization will be carefully considered
• Condition: Hemophilia A

Intervention

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

Study Groups/Cohorts

Damoctocog alfa pegol

Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.

Intervention: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 2, 2023): 62
• Original Estimated Enrollment (submitted: July 2, 2020): 50
• Estimated Study Completion Date: June 30, 2028
• Estimated Primary Completion Date: June 30, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Greece, Italy, Slovenia, Spain
• Removed Location Countries: Belgium, Denmark, France, Luxembourg, Netherlands, Norway, Russian Federation, Sweden, United Kingdom

Administrative Information

• NCT Number: NCT04461639
• Other Study ID Numbers: 20904
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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.

• Current Responsible Party: Bayer
• Original Responsible Party: Same as current
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bayer
• Verification Date: May 2024