Hemophilia APhase 4PREDICTNCT05036278
Prophylaxis Regimen for Hemophilia A Patients
A Phase 4 study testing Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG). in people with Hemophilia A and Prophylaxis of Bleeding, run by Bayer at 12 sites in United States.
Trial summary
Researchers are looking for a better way to treat people who have hemophilia A. Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A, Prophylaxis of Bleeding
- What is being tested?
- Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 12 sitesUnited States
- Study dates
- 28 Jul 2022to 12 Sep 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be ≥ 12 years of age inclusive, at the time of signing the informed consent/assent.
- Previously treated patients (≥ 150 EDs) with congenital hemophilia A.
- Prophylaxis with any SHL FVIII product with a stable frequency for at least 6 consecutive months within the last 12 months prior to screening before entering the study and documented in medical records. Stable frequency is defined as a minimum 18 weeks of treatment in a 6 (consecutive) calendar month period in the 12 months prior to screening. Patients can be on any non-Jivi EHL between the 6-month stable SHL prophylaxis period and start of study treatment.
- Documented bleeding rate (ABR) while on stable frequency SHL prophylaxis for at least 6 consecutive months within the last 12 months prior to screening.
- No current evidence (≥ 0.6 BU/mL) of FVIII inhibitors. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL on two occasions) but has been tolerized for at least 1 year since the last positive titer with at least 1 negative inhibitor assay test during that period, they can be enrolled. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL) but did not require tolerization and has had at least 1 negative inhibitor assay test during a minimum period of at least 1 year since the last positive titer, they can be enrolled.
- If they are human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4+) lymphocyte count should be > 200/mm^3 within 1 year before entering the study and documented in medical records. -
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- Participants who are willing to complete an electronic diary (eDiary).
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- For adolescent participants (≥ 12 to < 18 years), a legal guardian must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of Activities (SoA) (e.g. able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the PROs during the scheduled study visits; accurately and reliably dispense study intervention as directed.
- For adolescent participants, a legal guardian must be able to accurately maintain the child's take-home record, including items of general health.
Who cannot join
- Any other inherited or acquired bleeding disorder in addition to hemophilia A. Note: von Willebrand disease should be diagnosed per local clinical practice. Participants with a diagnosis of von Willebrand disease in medical records or diagnosed at the time of screening will be excluded.
- Platelet count < 100,000/mm^3
- Evidence of inhibitor to FVIII (≥ 0.6 BU/mL) within the last 1 year
- The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug or device within 30 days of signing informed consent.
- The participant has a planned major surgery.
- Documentation of missing risk score parameters other than physical activity .
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- Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
- Any other significant medical condition that the investigator feels would be a risk to the participant or would impede the study.
- Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
- Otherwise vulnerable participants (e.g. participants who are in custody by order of an authority).
- Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures (i.e. eDiary completion, clinic visits, phone updates), restrictions, and requirements.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Aflac Cancer and Blood Disorders Center - Egleston Hospital
Atlanta, Georgia, 30301
Wellstar MCG Health Medical Center - Gynecology
Augusta, Georgia, 30912
University of Colorado | Renal Research Office
Aurora, Colorado, 80045
Rush University Medical Center - Oncology
Chicago, Illinois, 60612
Gulf States Hemophilia & Thrombophilia Center- Texas Medical Center
Houston, Texas, 77030
Stead Family Children's Hospital - Hematology / Oncology
Iowa City, Iowa, 52240
Dr. Akshat Jain - Loma Linda University Medical Center
Loma Linda, California, 92354
Loma Linda University Children's Hospital - Hematology / Oncology
Loma Linda, California, 92354
Luskin Orthopaedic Institute for Children
Los Angeles, California, 90001
UHealth - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Rutgers Robert Wood Johnson Medical School - OBGYN
New Brunswick, New Jersey, 08901
About this study
Official title: A Multicenter, Prospective, Open-label, Clinical Study to Assess the Effect of Using a New Risk Score Approach to Select the Most Appropriate Prophylaxis Regimen for Reaching a Favorable Outcome, When Hemophilia A Patients Switch From Standard Half-life Products to Damoctocog Alfa Pegol (Jivi)
Researchers are looking for a better way to treat people who have hemophilia A. Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
Read more
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have become available. These products last longer in the body so that they require to be given less often with injections every 3-5 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on their experience.
The main purpose of this study is to learn how well a new scoring approach works to select a treatment plan for the prevention of bleeding in people with hemophilia A who switch their treatment from SHL products to Jivi. Different types of information are used to calculate the risk score like bleeding history, certain biological factors, and physical activity of the participant.
All participants will receive Jivi for 6 months.
In the first four weeks, all participants will receive Jivi 2 times a week at a dose level of 40 IU per kilogram body weight (also known as 40 IU/kg/dose, recommended maximum dose is 6,000 IU). Then, based on their risk score, each participant will be assigned to one of three treatment plans:
- participants with a high risk remain on Jivi administration 2 times a week at 40 IU/kg/dose
- participants with a medium risk will switch to Jivi administration every 5 days at 50 IU/kg/dose
- participants with a low risk will switch to Jivi administration every 5 days at 50 IU/kg/dose and after 4 weeks to a less frequent administration (e.g., every 7 days) at 60 IU/kg/dose To check how well the new scoring approach works for choosing the right treatment plan, researchers will look at how many participants have a favourable outcome.
This means that the participant has either fewer bleeding events vs. the pre-study treatment and takes Jivi less often or as often as the previous SHL treatment but with fewer bleeding events, or that the participant has a comparable number of bleeding events but needs to take Jivi less often than the previous treatment. Each participant will be in the study for approximately 7.5 months. During this time, 4 visits to the study site and 3 phone calls are planned. During the study, the doctors and their study team will: • do physical examinations • take blood samples • ask the participants questions about how they are feeling and what adverse events they are having. In addition, participants or their guardians are required to write down the dates of Jivi treatments and bleeding events in an electronic diary and to fill in different questionnaires on their quality of life, health status, work/ school productivity, pain, and treatment satisfaction. In addition, participants are expected to keep appointments for visits and to adhere to the assigned treatment regimen.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
- Conditions
- Hemophilia A, Prophylaxis of Bleeding
- Being tested
- Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).Biological
Also called Jivi, BAY94-9027
Dosage Levels:
- 40 IU/kg/dose two times per week
- 50 IU/kg/dose every 5 days
- 60 IU/kg/dose, Less frequent dosing (e.g. every 7 days), the total recommended maximum dose/infusion is 6000 IU.
| Study group | Role | What they receive |
|---|---|---|
| Damoctocog alfa-pegol prophylaxis regimens | Experimental | Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose). Receives: Biological: Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen
Overall number of participants with favorable outcomes after prophylaxis regimen assignment by a risk score, based on a participant's baseline phenotypic and biologic variables, when switching from a standard half-life (SHL) product to Jivi.
Measured: up to 6 months
Secondary outcomes (10)
Annualized Bleeding Rate (ABR) (Total, Joint, Spontaneous)
To assess the efficacy of Jivi
Measured: up to 6 months
Change in Total ABR From Pre-study
To assess the efficacy of Jivi compared to a previous SHL treatment.
Measured: up to 6 months
Change in the Frequency of Pre-study SHL Teratment to the Frequency of Jivi Administration (Infusions/Month)
To assess the frequency of Jivi administration.
Measured: up to 6 months
Occurrence of Participants With 0 and ≤ 1 Spontaneous Bleeds
To assess the proportion of participants with 0 and ≤ 1 spontaneous bleeds.
Measured: up to 6 months
Change in Haemophilia Quality of Life Questionnaire (Haem-A-QoL or Haemo-QoL)
To assess participant quality of life (QoL) and physical activity, as measured by the Patient Reported Outcomes (PROs) Hemophilia A-specific quality of life and Hemophilia-specific quality of life. This includes 41 items covering 6 domains: Physical Functioning, Role Functioning, Worry, Consequences of Bleeding, Emotional Impact, and Treatment Concerns. The Haemo-QoL Short Form contains 35 items covering 9 domains: Physical Health, View of Yourself, Family, Friends, Others, Sports, Dealing, and Treatment. A higher score on the questionnaire represents greater impairment, and a negative change from baseline represents improvement. The percentage score is sum of item scores divided by the possible range. Individual item scores range from 1 to 5.
Measured: up to 6 months
Patient's Global Impression of Change (PGI-C)
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs).
Measured: up to 6 months
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs). Change to baseline means changes between Visit 2 and Visit 6
Measured: up to 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM)
To assess participant quality of life (QoL) and physical activity, as measured by Patient-Reported Outcomes (PROs). Score ranges from 10 (lowest satisfaction) to 100 (greatest satisfaction).
Measured: up to 6 months
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Work Productivity and Activity Impairment Questionnaire scores for hemophilia effect over the last 7 days on productivity or ability at work, at school, and in regular daily activities. It ranges from 0% to 100%, where higher scores indicate greater work impairment and less productivity.
To assess participant quality of life (QoL) and physical activity, as measured by Patient Reported Outcomes (PROs). Baseline = Visit 2, Change from Baseline = Visit 6
Measured: up to 6 months
Number of Target Joints and Change in Target Joint Status From Baseline
To assess target joint status, per modified International Society on Thrombosis and Haemostasis (ISTH) guidelines
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start28 Jul 2022
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036278
- Sponsor's protocol ID
- 21924
- Other IDs
- 2021-006191-16
- Acronym
- PREDICT
- Status last verified
- Oct 2025
- First submitted
- 2 Sep 2021
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Quon DV, Escobar M, Boggio L, Corrales-Medina FF, Jain A, Reding MT, Sidonio RF Jr, Staber JM, Charlet J. A New Risk-Based Scoring Approach to Individualize Prophylaxis in Patients with Hemophilia A: Results from the PREDICT Study. Adv Ther. 2026 Jul;43(7):2913-2929. doi: 10.1007/s12325-026-03560-0. Epub 2026 Mar 26.
PubMed 41886249
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-label, Clinical Study to Assess the Effect of Using a New Risk Score Approach to Select the Most Appropriate Prophylaxis Regimen for Reaching a Favorable Outcome, When Hemophilia A Patients Switch From Standard Half-life Products to Damoctocog Alfa Pegol (Jivi)
- ClinicalTrials.gov ID
- NCT05036278
- Acronym / sponsor ID
- PREDICT / 21924
- Conditions
- Hemophilia A, Prophylaxis of Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat people who have hemophilia A. Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have become available. These products last longer in the body so that they require to be given less often with injections every 3-5 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on their experience.
The main purpose of this study is to learn how well a new scoring approach works to select a treatment plan for the prevention of bleeding in people with hemophilia A who switch their treatment from SHL products to Jivi. Different types of information are used to calculate the risk score like bleeding history, certain biological factors, and physical activity of the participant.
All participants will receive Jivi for 6 months.
In the first four weeks, all participants will receive Jivi 2 times a week at a dose level of 40 IU per kilogram body weight (also known as 40 IU/kg/dose, recommended maximum dose is 6,000 IU). Then, based on their risk score, each participant will be assigned to one of three treatment plans:
- participants with a high risk remain on Jivi administration 2 times a week at 40 IU/kg/dose
- participants with a medium risk will switch to Jivi administration every 5 days at 50 IU/kg/dose
- participants with a low risk will switch to Jivi administration every 5 days at 50 IU/kg/dose and after 4 weeks to a less frequent administration (e.g., every 7 days) at 60 IU/kg/dose To check how well the new scoring approach works for choosing the right treatment plan, researchers will look at how many participants have a favourable outcome.
This means that the participant has either fewer bleeding events vs. the pre-study treatment and takes Jivi less often or as often as the previous SHL treatment but with fewer bleeding events, or that the participant has a comparable number of bleeding events but needs to take Jivi less often than the previous treatment. Each participant will be in the study for approximately 7.5 months. During this time, 4 visits to the study site and 3 phone calls are planned. During the study, the doctors and their study team will: • do physical examinations • take blood samples • ask the participants questions about how they are feeling and what adverse events they are having. In addition, participants or their guardians are required to write down the dates of Jivi treatments and bleeding events in an electronic diary and to fill in different questionnaires on their quality of life, health status, work/ school productivity, pain, and treatment satisfaction. In addition, participants are expected to keep appointments for visits and to adhere to the assigned treatment regimen.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Damoctocog alfa-pegol prophylaxis regimens | Experimental | Biological: Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must be ≥ 12 years of age inclusive, at the time of signing the informed consent/assent.
- Previously treated patients (≥ 150 EDs) with congenital hemophilia A.
- Prophylaxis with any SHL FVIII product with a stable frequency for at least 6 consecutive months within the last 12 months prior to screening before entering the study and documented in medical records. Stable frequency is defined as a minimum 18 weeks of treatment in a 6 (consecutive) calendar month period in the 12 months prior to screening. Patients can be on any non-Jivi EHL between the 6-month stable SHL prophylaxis period and start of study treatment.
- Documented bleeding rate (ABR) while on stable frequency SHL prophylaxis for at least 6 consecutive months within the last 12 months prior to screening.
- No current evidence (≥ 0.6 BU/mL) of FVIII inhibitors. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL on two occasions) but has been tolerized for at least 1 year since the last positive titer with at least 1 negative inhibitor assay test during that period, they can be enrolled. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL) but did not require tolerization and has had at least 1 negative inhibitor assay test during a minimum period of at least 1 year since the last positive titer, they can be enrolled.
Key exclusion criteria (11 listed)
- Any other inherited or acquired bleeding disorder in addition to hemophilia A. Note: von Willebrand disease should be diagnosed per local clinical practice. Participants with a diagnosis of von Willebrand disease in medical records or diagnosed at the time of screening will be excluded.
- Platelet count < 100,000/mm^3
- Evidence of inhibitor to FVIII (≥ 0.6 BU/mL) within the last 1 year
- The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug or device within 30 days of signing informed consent.
- The participant has a planned major surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).Also: Jivi, BAY94-9027Dosage Levels: * 40 IU/kg/dose two times per week * 50 IU/kg/dose every 5 days * 60 IU/kg/dose, Less frequent dosing (e.g. every 7 days), the total recommended maximum dose/infusion is 6000 IU. | Biological | Damoctocog alfa-pegol prophylaxis regimens |
Primary outcome
Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen
Time frame: up to 6 months
Overall number of participants with favorable outcomes after prophylaxis regimen assignment by a risk score, based on a participant's baseline phenotypic and biologic variables, when switching from a standard half-life (SHL) product to Jivi.
10 secondary outcomes
Annualized Bleeding Rate (ABR) (Total, Joint, Spontaneous)
Time frame: up to 6 months
Change in Total ABR From Pre-study
Time frame: up to 6 months
Change in the Frequency of Pre-study SHL Teratment to the Frequency of Jivi Administration (Infusions/Month)
Time frame: up to 6 months
Occurrence of Participants With 0 and ≤ 1 Spontaneous Bleeds
Time frame: up to 6 months
Change in Haemophilia Quality of Life Questionnaire (Haem-A-QoL or Haemo-QoL)
Time frame: up to 6 months
Patient's Global Impression of Change (PGI-C)
Time frame: up to 6 months
EuroQoL 5 Dimensions (EQ-5D-5L) Questionnaire
Time frame: up to 6 months
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: up to 6 months
Work Productivity and Activity Impairment (WPAI) Questionnaire Scores
Time frame: up to 6 months
Number of Target Joints and Change in Target Joint Status From Baseline
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41886249Quon DV, Escobar M, Boggio L, Corrales-Medina FF, Jain A, Reding MT, Sidonio RF Jr, Staber JM, Charlet J. A New Risk-Based Scoring Approach to Individualize Prophylaxis in Patients with Hemophilia A: Results from the PREDICT Study. Adv Ther. 2026 Jul;43(7):2913-2929. doi: 10.1007/s12325-026-03560-0. Epub 2026 Mar 26.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG). in people with Hemophilia A and Prophylaxis of Bleeding, run by Bayer at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Number of Participants With Favorable Outcome on the Score-assigned Prophylaxis Regimen (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.