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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003655-37 | EudraCT Number |
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The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient's wellbeing will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe hemophilia A patients | Other | Prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damoctocog alfa pegol (Jivi, BAY94-9027) | Drug | The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| FVIII Inhibitor Development by the Nijmegen Bethesda Assay | FVIII inhibitor testing was performed using the Nijmegen-modified Bethesda assay. A positive inhibitor result was defined as a threshold of ≥0.6 BU/mL at the central laboratory and had to be confirmed with a second blood sample. After confirmation of the positive result, the inhibitor was to be reported as a serious adverse event (SAE). | Observed for 100 exposure days (EDs), up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent AEs were defined as those that started after the first dose of study drug and up to 7 days after the last dose. | Observed for 100 exposure days (EDs), up to 2 years |
| Development of Treatment-emergent Anti-PEG Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT Tsaritsa Joanna-ISUL EAD Sofia | Sofia | 1527 | Bulgaria | |||
| MHAT Sveta Marina EAD |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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36 participants were screened into the study (signed informed consent form (ICF)). 4 participants were screening failed.
The study was conducted at 13 centers in 7 countries between 23 SEP 2019 (First participant first visit) and 26 Aug 2022 (last participant's data from the last visit were received). Bulgaria (2 centers), Denmark (1 centers), Spain (3 centers), Greece (1 center), Italy (3 centers), Norway (1 center), Poland (2 centers).
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| ID | Title | Description |
|---|---|---|
| FG000 | Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment | Prophylaxis regimens with every 5 days treatment (45-60 IU/kg), or every 7 days (60 IU/kg) or twice per week (40 IU/kg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2020 | May 7, 2023 |
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Anti-PEG antibody: antibody against the PEG moiety determined by enzyme-linked immunosorbent assay (ELISA). For participants with a positive result, IgM antibodies were tested. |
| Observed for 100 exposure days (EDs), up to 2 years |
| Annualized Bleeding Rate (ABR) | ABR is number of all bleeds per individual treatment period annualized to a 1-year time interval. | Observed for 100 exposure days (EDs), up to 2 years |
| Varna |
| 9010 |
| Bulgaria |
| Aarhus Universitetshospital, Skejby | Arhus N | 8200 | Denmark |
| LAIKO General Hospital of Athens | Athens | 115 27 | Greece |
| A.O. Pugliese-Ciaccio | Catanzaro | Calabria | 88100 | Italy |
| A.O.U. Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| Oslo Universitetssykehus HF, Rikshospitalet | Oslo | 0372 | Norway |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| SP Szpital Kliniczny Nr 1 | Wroclaw | 50-367 | Poland |
| Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario "La Paz" | Madrid | 28046 | Spain |
| Hospital Universitari i Politecnic La Fe | Hematologia | Valencia | 46026 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment | Prophylaxis regimens with every 5 days treatment (45-60 IU/kg), or every 7 days (60 IU/kg) or twice per week (40 IU/kg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FVIII Inhibitor Development by the Nijmegen Bethesda Assay | FVIII inhibitor testing was performed using the Nijmegen-modified Bethesda assay. A positive inhibitor result was defined as a threshold of ≥0.6 BU/mL at the central laboratory and had to be confirmed with a second blood sample. After confirmation of the positive result, the inhibitor was to be reported as a serious adverse event (SAE). | Safety analysis set (SAF): A participant was included in the SAF if he received at least 1 infusion of study drug. | Posted | Number | Participants | Observed for 100 exposure days (EDs), up to 2 years |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent AEs were defined as those that started after the first dose of study drug and up to 7 days after the last dose. | Safety analysis set (SAF): A participant was included in the SAF if he received at least 1 infusion of study drug. | Posted | Number | participants | Observed for 100 exposure days (EDs), up to 2 years |
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| Secondary | Development of Treatment-emergent Anti-PEG Antibodies | Anti-PEG antibody: antibody against the PEG moiety determined by enzyme-linked immunosorbent assay (ELISA). For participants with a positive result, IgM antibodies were tested. | Safety analysis set (SAF): A participant was included in the SAF if he received at least 1 infusion of study drug. | Posted | Number | participants | Observed for 100 exposure days (EDs), up to 2 years |
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| Secondary | Annualized Bleeding Rate (ABR) | ABR is number of all bleeds per individual treatment period annualized to a 1-year time interval. | Modified intent-to-treat set (mITT): A participant was included in the mITT if he received at least 1 infusion of study drug and had injection/bleeding data available for at least 3 months. This time period is considered the minimum observation time for a reliable annualization of the observed bleed rate. | Posted | Median | Inter-Quartile Range | Bleeds per year | Observed for 100 exposure days (EDs), up to 2 years |
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Timeframe for TEAEs: After the first study intervention up to 7 days after the end of study intervention, with an average of 475 days. Timeframe for the all-cause mortality: All deaths that occurred at any time during the study before the last contact, with an average of 476 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment | Prophylaxis regimens with every 5 days treatment (45-60 IU/kg), or every 7 days (60 IU/kg) or twice per week (40 IU/kg). | 0 | 32 | 2 | 32 | 15 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (25.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2022 | May 7, 2023 | SAP_001.pdf |
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| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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