PF-06835375 for Low Platelet Count
Trial Summary
What is the purpose of this trial?
This trial uses a new injectable medicine called PF-06835375. It targets adults with long-lasting or chronic low platelet counts due to primary immune thrombocytopenia (ITP). The medicine works by reducing specific immune cells to help increase platelet counts.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What evidence supports the effectiveness of the drug PF-06835375 for low platelet count?
The research mentions that thrombopoietin and its analogues, which are similar to PF-06835375, have been shown to be potent stimulators of platelet production and can enhance platelet recovery after chemotherapy. Additionally, other thrombopoietin receptor agonists like romiplostim and avatrombopag have been effective in increasing platelet counts in patients with immune thrombocytopenia.12345
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for adults with primary immune thrombocytopenia (ITP) who have had low platelet counts for more than 3 months. They shouldn't have had severe bleeding in the last month or need blood products during screening, and they can't join if they've had a splenectomy within the past 3 months or plan to have one.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of PF-06835375 once monthly. Cohort 1 receives treatment for 3 months, while cohorts 2 and 3 receive treatment for 4 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on changes in platelet counts.
Treatment Details
Interventions
- PF-06835375
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University