NCT05070845 Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
| NCT ID | NCT05070845 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pfizer |
| Condition | Primary Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 91 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2028-08-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 91 participants in total. It began in 2022-02-02 with a primary completion date of 2028-08-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT05070845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05070845 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05070845 currently recruiting?
Yes, NCT05070845 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT05070845 trial being conducted?
This trial is being conducted at Greenville, United States, Liverpool, Australia, Liverpool, Australia, Mount Kuring-Gai, Australia and 11 additional locations.
Who is sponsoring the NCT05070845 clinical trial?
NCT05070845 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 91 participants.