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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.
Must not have
Current unstable liver or biliary disease
Abnormal renal or hepatic function
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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver condition is stable.
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My kidney or liver is not functioning properly.
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I am HIV-positive with a CD4 count of 200 or less.
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I am currently taking medication that affects my immune system.
Select...
I have previously taken part in studies B7841002 or B7841003 involving PF 06741086.
Select...
I have had treatment for heart or blood vessel problems.
Select...
I have a surgery planned during the study period.
Select...
I have a bleeding disorder that is not hemophilia A or B.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through observational phase (6months) and active treatment phase (12 months) for total of approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through observational phase (6months) and active treatment phase (12 months) for total of approximately 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized bleeding rate (ABR) of treated bleeding events

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03363321
40%
Haemarthrosis
20%
Tonsillitis
20%
Disorientation
20%
Contusion
20%
Arthralgia
20%
Skull fracture
20%
Inflammation
20%
Cerebral haemorrhage
20%
Generalised tonic-clonic seizure
20%
Injection site haematoma
20%
Injection site reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: 300mg - 300mg Non-Inhibitor
Cohort 2: 300mg Loading + 150mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 4: 300mg - 300mg Inhibitor
Cohort 3: 450mg - 300mg Loading + 150mg Non-Inhibitor
Cohort 5: De Novo 300mg Loading + 150mg Inhibitors

Awards & Highlights

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.

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
4,658 Previous Clinical Trials
17,877,097 Total Patients Enrolled
21 Trials studying Hemophilia B
4,902 Patients Enrolled for Hemophilia B
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,273 Total Patients Enrolled
22 Trials studying Hemophilia B
1,928 Patients Enrolled for Hemophilia B

Media Library

PF-06741086 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03938792 — Phase 3
Hemophilia B Research Study Groups: PF-06741086
Hemophilia B Clinical Trial 2023: PF-06741086 Highlights & Side Effects. Trial Name: NCT03938792 — Phase 3
PF-06741086 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03938792 — Phase 3
~18 spots leftby Jun 2025
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