RECRUITING

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

Description

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP

Conditions

Primary Immune Thrombocytopenia
Talk to us

Related Conditions:

Primary Immune Thrombocytopenia

Study Overview

On this page

Study Details

Study overview

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP

AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

Condition
Primary Immune Thrombocytopenia
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Bethesda

American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States, 20817

Bethesda

American Oncology Partners of MD, PA, Bethesda, Maryland, United States, 20817

Germantown

American Oncology Partners of Maryland, PA, Germantown, Maryland, United States, 20874

Nyack

Hematology Oncology Associates of Rockland, Nyack, New York, United States, 10960

Greenville

East Carolina University, Greenville, North Carolina, United States, 27834

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of Primary ITP. Ongoing ITP (platelet counts \<50 x 109/L) \[No severe bleeding within 1 month or during screening\] AND Persistent ITP (3 to 12 months) or Chronic ITP \>12 months
  • * Bleeding event according to the WHO grading scale ≥2 occurring ≤4 weeks prior to screen OR a current bleeding event that, in the opinion of the investigator, requires treatment with standard of care therapy OR require blood or blood products during screening
  • * Splenectomy within 3 months of randomization or planned during the study duration.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-10-27