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Monoclonal Antibodies
PF-06741086 for Hemophilia
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Participants on FVIII/FIX routine prophylaxis who have demonstrated at least 80% compliance with scheduled prophylaxis regimen during 6 months prior to enrollment and are willing to continue to receive routine prophylaxis treatment with FVIII/FIX replacement during the Observational Phase.
- Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months period prior to enrollment and willing to continue to receive on demand treatment during the Observational Phase.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through observational phase (6months) and active treatment phase (12 months) for total of approximately 18 months
Awards & highlights
Study Summary
This trial is testing a new drug for hemophilia A or B that works differently than current treatments and doesn't require as frequent administration.
Who is the study for?
Adults and teens with severe Hemophilia A or moderately to severely severe Hemophilia B, weighing at least 35 kg. They must have a history of compliance with their current treatment regimen, no inhibitors for non-inhibitor cohort, or specific inhibitor criteria for the inhibitor cohort. Exclusions include planned surgeries, other hemostatic defects, abnormal organ function, certain drug therapies including gene therapy for hemophilia.Check my eligibility
What is being tested?
PF-06741086 is being tested as a potential new treatment option for Hemophilia A and B. It's given once weekly through subcutaneous injection and may offer benefits over existing treatments by working differently than factor replacement products and being effective even in the presence of inhibitors.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from similar treatments can include reactions at the injection site such as pain or swelling, headache, feverish symptoms. Since it's an investigational product more specific side effects will be determined during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have followed my clotting factor treatment plan closely for the last 6 months.
Select...
I've needed infusions for bleeding 6+ times in the last 6 months and will continue treatment.
Select...
My blood tests show I have a resistance to clotting factor treatments.
Select...
I have severe hemophilia A or B and weigh at least 35 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through observational phase (6months) and active treatment phase (12 months) for total of approximately 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through observational phase (6months) and active treatment phase (12 months) for total of approximately 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized bleeding rate (ABR) of treated bleeding events
Incidence and severity of injection site reaction
Incidence and severity of thrombotic events
+9 moreSecondary outcome measures
Change from baseline in (Haemophilia Adult Quality of Life Questionnaire (Haem-A-QoL)
Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
Change from baseline in Haemophilia Quality of Life Questionnaire for Children (Haemo-QoL)
+8 moreSide effects data
From 2020 Phase 2 trial • 20 Patients • NCT0336332125%
Haemarthrosis
25%
Haematoma
25%
Skin haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 5: De Novo 300mg Loading + 150mg Inhibitors
Cohort 4: 300mg - 300mg Inhibitor
Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 1: 300mg - 300mg Non-Inhibitor
Trial Design
1Treatment groups
Experimental Treatment
Group I: PF-06741086Experimental Treatment1 Intervention
Participants will be assigned to treatment with PF-06741086 after a 6 month Observation Phase on their current hemophilia regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06741086
2021
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,688 Total Patients Enrolled
43 Trials studying Hemophilia A
6,029 Patients Enrolled for Hemophilia A
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,856 Total Patients Enrolled
42 Trials studying Hemophilia A
2,770 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I, or someone legally allowed to make decisions for me, can sign the consent form.My liver condition is stable.I am using or plan to use immune tolerance therapy or clotting factor replacements during the study.I am currently on or have had treatments for hemophilia that aren't factor replacement.You are allergic to hamster protein or any other parts of the study treatment.I've needed infusions for bleeding 6+ times in the last 6 months and will continue treatment.You have a medical or mental health condition that could make it risky for you to participate in the study or could affect the study results.I am HIV-positive with a CD4 count of 200 or less.My blood tests show I have a resistance to clotting factor treatments.My kidney or liver is not functioning properly.I have followed my clotting factor treatment plan closely for the last 6 months.I am currently taking medication that affects my immune system.I have severe hemophilia A or B and weigh at least 35 kg.I have had inhibitors to clotting factor therapy but don't currently meet the specific inhibitor level criteria.I have hemophilia and needed treatment for multiple bleeding episodes recently.I have followed my bleeding prevention treatment plan closely for the last 6 months.I have previously taken part in studies B7841002 or B7841003 involving PF 06741086.I have had treatment for heart or blood vessel problems.I have a surgery planned during the study period.I have not been in a drug or vaccine study within the last 30 days or 5 half-lives.I have a bleeding disorder that is not hemophilia A or B.
Research Study Groups:
This trial has the following groups:- Group 1: PF-06741086
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with certain medical conditions still able to join this research project?
"Yes, this study is currently still recruiting patients. The listing on clinicaltrials.gov shows that the trial was first posted on March 9th 2020 and was last updated on October 24th 2022."
Answered by AI
Are there specific inclusion criteria for this clinical trial?
"Patients that have hemophilia a and are between 12 to 74 years old qualify for this trial. A total of 145 people will be accepted."
Answered by AI
How many people total have signed up for this experiment?
"Indeed, the trial is still open and recruiting patients from 9 different locations. According to the website, they are looking for 145 individuals in total."
Answered by AI
Are there any know serious side effects of PF-06741086?
"There is available data that supports the efficacy of PF-06741086 and it has undergone multiple rounds of testing for safety, so it received a score of 3."
Answered by AI
Does this test involve elderly people?
"To be eligible for this study, patients must fall between the ages of 12 and 74. There are a total of 41 clinical trials taking place for people under 18 and 66 medical studies underway for senior citizens."
Answered by AI
In how many different places can patients participate in this trial?
"To limit travel burdens for participants, the 9 sites for this clinical trial are all located close to each other. The cities where these medical centres are based include Hamilton, New Hyde Park and Toronto."
Answered by AI
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