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PF-06462700

Phase 3

Aplastic Anemia | Monoclonal antibody | Hematology |Pfizer, Inc.|Last Updated: Apr 27, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

PF-06462700 · 1 trial · 1 indication

Phase 3 1
NCT04350606A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic AnemiaAplastic Anemia
COMPLETED3 Analytics
PHASE3COMPLETED
A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia
Aplastic AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Hematologic Response at Week 12
Week 12 Follow-up Visit

Hematologic response was considered to be "effective" when 2 or more of the following criteria were met: absolute neutrophil count greater than or equal to (\>=) 500 per microliters, platelet count \>=20,000 per microliters and reticulocyte count \>=60,000 per microliters was observed. In this outcome measure, number of participants with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not considered as fulfilling response criteria.

Secondary Endpoints

Number of Participants With Hematologic Response at Week 24
Week 24 Follow-up Visit
Absolute Neutrophil Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24
Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
Platelet Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24
Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-006462700 groupEXPERIMENTALAll enrolled participants will be administrated PF-006462700.

Interventions

NameTypeDescription
PF-06462700BIOLOGICALPF-06462700 is classified as an immunosuppressant/ immunosuppressive agent. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric immunoglobulin G (IgG), from hyperimmune serum of horses that are immunized with human thymus lymphocytes.
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male or female participants between the ages of 2 years and more, inclusive, at Visit 1 (Screening). * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Have a...

Countries:Japan
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Competitive Landscape -Aplastic Anemia 4 trials

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Frequently asked questions about PF-06462700

What is PF-06462700 used for?

PF-06462700 is an investigational monoclonal antibody being developed for the treatment of aplastic anemia, a condition where the bone marrow fails to produce enough blood cells. It is currently in Phase 3 clinical development, though the specific mechanism of action has not been disclosed.

Who makes PF-06462700?

PF-06462700 is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 3 clinical development for aplastic anemia.

What phase is PF-06462700 in?

PF-06462700 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed, but the drug remains under investigation for aplastic anemia.

What clinical trials is PF-06462700 in?

PF-06462700 has one completed Phase 3 trial, identified as NCT04350606, which assessed its efficacy and safety in Japanese participants with aplastic anemia. The trial enrolled 3 participants and was not randomized or double-blinded.

Is PF-06462700 the same as any other drug?

No alternative names for PF-06462700 have been disclosed. It is identified solely by its investigational code, PF-06462700, and is being studied as a monoclonal antibody for aplastic anemia.