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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509338-21-00 | Registry Identifier | CTIS (EU) |
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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
This study is designed to elucidate the effects of PF-06835375 on platelet counts in participants with moderate to severe primary ITP. Based on the experience with other B-cells depleting agents, it is expected that the platelet counts will increase following a standard treatment. Each participant in cohort 1 received 1 subcutaneous injection of dose 1 every month for 3 months during the 12-week treatment period. Each participant in cohorts 2, 3, or 4 (will) receive(d) subcutaneous injection(s) of dose 2, 3, or 4 every month for 4 months during the 16-week treatment period. This should provide sufficient levels of exposure and depletion of CXCR5 positive cells to sustain the effects of PF-06835375 during the treatment period. Additional depletion of Tfh cells may provide sustained increase in platelet count following the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label PF-06835375 dose 1 Treatment | Experimental | subcutaneous injection once monthly for 3 months |
|
| Open Label PF-06835375 dose 2 Treatment | Experimental | subcutaneous injection once monthly for 4 months |
|
| Open Label PF-06835375 dose 3 Treatment | Experimental | subcutaneous injection once monthly for 4 months |
|
| Open Label PF-06835375 dose 4 Treatment | Experimental | subcutaneous injections once monthly for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06835375 | Biological | CXCR5 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with change from baseline of platelet counts | To evaluate absolute value of platelet count of treated participants | baseline through 12 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of participants with modified overall response (mOR) | To evaluate the modified overall response of platelet count of treated participants | baseline through 12 and 16 weeks |
| proportion of participants with complete response (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Carolina University | Recruiting | Greenville | North Carolina | 27834 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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open label
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To evaluate the complete response of platelet count of treated participants
| baseline through 12 and 16 weeks |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | baseline through end of study (Week 20 for cohort 1 and Week 24 for cohorts 2 and 3) |
| Proportion of participants with change from baseline of platelet counts | baseline to Week 20 and Week 24 |
| Proportion of participants with change from baseline of circulating B cells | baseline to Week 20 and Week 24 |
| Proportion of participants with change from baseline of circulating cTfh cells | baseline to Week 20 and Week 24 |
| Liverpool Hospital |
| Recruiting |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| South West Radiology | Recruiting | Liverpool | New South Wales | 2170 | Australia |
| Slade Pharmacy | Recruiting | Mount Kuring-Gai | New South Wales | 2080 | Australia |
| Calvary Mater Newcastle | Recruiting | Waratah | New South Wales | 2298 | Australia |
| Flinders Medical Centre | Recruiting | Bedford Park | South Australia | 5042 | Australia |
| ICON Cancer Centre - Kurralta Park | Recruiting | Kurralta Park | South Australia | 5037 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Royal Perth Hospital | Recruiting | Perth | Western Australia | 6000 | Australia |
| Unity Health Toronto, St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Ostrava | Recruiting | Ostrava - Poruba | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Recruiting | Prague | 100 34 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
| Pécsi Tudományegyetem Klinikai Központ | Active, not recruiting | Pécs | Baranya | 7624 | Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház | Recruiting | Kaposvár | Somogy County | 7400 | Hungary |
| Semmelweis University | Recruiting | Budapest | 1088 | Hungary |
| Petz Aladár Egyetemi Oktató Kórház | Recruiting | Győr | 9024 | Hungary |
| Tolna Varmegyei Balassa Janos Korhaz | Not yet recruiting | Szekszárd | 7100 | Hungary |
| Komárom-Esztergom Vármegyei Szent Borbála Kórház | Not yet recruiting | Tatabánya | H-2800 | Hungary |
| AIDPORT Sp. z o.o. | Recruiting | Skórzewo | Greater Poland Voivodeship | 60-185 | Poland |
| InterHem | Active, not recruiting | Bialystok | 15-732 | Poland |
| Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne | Active, not recruiting | Gdansk | 80-214 | Poland |
| Pratia Onkologia Katowice | Recruiting | Katowice | 40-519 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Active, not recruiting | Poznan | 60-569 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Recruiting | Wroclaw | 50-367 | Poland |
| Addenbrooke's Hospital | Recruiting | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
| Derriford Hospital | Recruiting | Plymouth | Devon | Pl6 8DH | United Kingdom |
| The Royal Cornwall Hospital | Recruiting | Truro | England | TR1 3LJ | United Kingdom |
| Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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