61 Participants Needed

PF-06835375 for Low Platelet Count

Recruiting at 37 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

How is the drug PF-06835375 different from other treatments for low platelet count?

There is no specific information available about PF-06835375 in the provided research articles, so its unique features compared to other treatments for low platelet count cannot be determined from this data.678910

Research Team

PC

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

I have been diagnosed with ITP and my platelet count is below 50, without severe bleeding in the last month.

Exclusion Criteria

I have had a significant bleeding event recently or need treatment for current bleeding.
I have had my spleen removed recently or will have it removed soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on changes in platelet counts.

4 weeks

Treatment Details

Interventions

  • PF-06835375
Trial OverviewThe study tests PF-06835375 through multiple subcutaneous injections to see if it's safe and effective for treating ITP. It's an open-label Phase 2 trial, meaning both researchers and participants know what treatment is being given.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Open Label PF-06835375 dose 3 TreatmentExperimental Treatment1 Intervention
subcutaneous injection once monthly for 4 months
Group II: Open Label PF-06835375 dose 2 TreatmentExperimental Treatment1 Intervention
subcutaneous injection once monthly for 4 months
Group III: Open Label PF-06835375 dose 1 TreatmentExperimental Treatment1 Intervention
subcutaneous injection once monthly for 3 months

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Interleukin-11 has been approved by the FDA for reducing severe thrombocytopenia in patients undergoing intensive chemotherapy, demonstrating its efficacy in this specific context.
While thrombopoietin and its analogues are potent stimulators of platelet production with few side effects, their effectiveness in preventing severe thrombocytopenia during leukemia treatment and bone marrow transplants has been disappointing, and some can induce harmful antibodies that lead to thrombocytopenia.
Clinical biology and potential use of thrombopoietin.Basser, R.[2019]
In a 52-week study involving 234 adults with immune thrombocytopenia, romiplostim significantly increased the rate of platelet response compared to standard care, with a response rate 2.3 times higher (P<0.001).
Patients receiving romiplostim experienced fewer treatment failures and required splenectomy less often (11% vs. 30% for standard care, P<0.001), along with lower rates of bleeding events and improved quality of life.
Romiplostim or standard of care in patients with immune thrombocytopenia.Kuter, DJ., Rummel, M., Boccia, R., et al.[2016]
In a 6-month Phase 3 study involving 49 adults with chronic immune thrombocytopenia (ITP), avatrombopag (20 mg/day) significantly improved platelet counts compared to placebo, with a median cumulative number of weeks of platelet response of 12.4 weeks versus 0 weeks for placebo (P < 0.0001).
Avatrombopag also demonstrated a higher platelet response rate at day 8 (65.63% vs. 0.0% for placebo, P < 0.0001) and reduced the need for concomitant ITP medications, while maintaining a safety profile similar to earlier studies, with common side effects being headache and contusion.
Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia.Jurczak, W., Chojnowski, K., Mayer, J., et al.[2019]

References

Clinical biology and potential use of thrombopoietin. [2019]
Romiplostim or standard of care in patients with immune thrombocytopenia. [2016]
Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. [2019]
Opportunities for the use of thrombopoietic growth factors. [2005]
Chronic immune thrombocytopenic purpura. New agents. [2016]
Intravenous and oral antiplatelet/antithrombotic efficacy and specificity of XR300, a novel nonpeptide platelet GPIIb/IIIa antagonist. [2019]
Inhibition of platelet aggregation by a new agent, 2,2'-dithiobis-(N-2-hydroxypropyl benzamide) (KF4939). [2019]
The in vivo pharmacological profile of the novel glycoprotein IIb/IIIa antagonist, SK&F 106760. [2003]
Ex vivo effects of SR 27417, a novel PAF antagonist, on rabbit platelet aggregation and [3H]-PAF binding. [2017]
CV3988 inhibits in vivo platelet aggregation induced by PAF-acether and collagen. [2019]