Phase
Condition
Platelet Disorders
Immune Thrombocytopenia (Itp)
White Cell Disorders
Treatment
Budoprutug
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 years at the time of consent.
Platelet count < 30,000/µL despite an adequate trial of at least one priortherapeutic attempt. Platelet counts of < 30,000/µL must be confirmed on 2 occasionsat least 5 days apart, but no more than 14 days apart.
Partial thromboplastin time < 1.5 x upper limit of normal (ULN), prothrombin time < 1.5 x ULN, total bilirubin < 1.5 x ULN unless due to Gilbert's syndrome, or aninternational normalized ratio < 1.5 at screening.
Exclusion
Exclusion Criteria:
CD19+ B cell count < 80 cells/µL at Screening, or < 40 cells/µL if B-cell depletingtherapy was received within 24 weeks to 2 years prior.
Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleedingdisorders affecting safety or data integrity.
Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first doseor planned during the study.
Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs,thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAIDuse is allowed.
Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life beforeScreening; alkylating agents within 180 days.
IVIg treatment within 90 days prior to Screening.
Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5×half-life before first dose, unless approved by Medical Monitor.
Active, chronic, or latent infections including hepatitis B/C or HIV.
Active TB or high TB risk.
Study Design
Study Description
Connect with a study center
Climb Bio Investigative Site #359202
Plovdiv 728193, 4002
BulgariaActive - Recruiting
Climb Bio Investigative Site #359203
Plovdiv 728193, 4003
BulgariaActive - Recruiting
Climb Bio Investigative Site #359201
Sofia 727011, 1797
BulgariaActive - Recruiting
Climb Bio Investigative Site #300204
Athens 264371, Attica 6692632 11527
GreeceSite Not Available
Climb Bio Investigative Site #300203
Chaïdári 260183, Attica 6692632 12462
GreeceSite Not Available
Climb Bio Investigative Site #300202
Ioannina 261779, 45500
GreeceSite Not Available
Climb Bio Investigative Site #300201
Thessaloniki 734077, 57010
GreeceSite Not Available
Climb Bio Investigative Site #381201
Belgrade,
SerbiaSite Not Available
Climb Bio Investigative Site #381202
Belgrade,
SerbiaSite Not Available
Climb Bio Investigative Site #381201
Belgrade 792680,
SerbiaActive - Recruiting
Climb Bio Investigative Site #381202
Belgrade 792680,
SerbiaActive - Recruiting
Climb Bio Investigative Site #381203
Novi Sad,
SerbiaSite Not Available
Climb Bio Investigative Site #381203
Novi Sad 3194360,
SerbiaActive - Recruiting
Climb Bio Investigative Site #340202
Cáceres 2520611, Attiki 100003
SpainSite Not Available
Climb Bio Investigative Site #340206
Burgos 3127461, 9006
SpainSite Not Available
Climb Bio Investigative Site #340204
Madrid 3117735, 28041
SpainSite Not Available
Climb Bio Investigative Site #340202
San Pedro 2511250,
SpainSite Not Available
Climb Bio Investigative Site #340203
Valencia 2509954, 46010
SpainSite Not Available
Climb Investigative Site
Ivano-Frankivs'k,
UkraineActive - Recruiting
Climb Investigative Site #380204
Ivano-Frankivs'k,
UkraineSite Not Available
Climb Investigative Site #380204
Ivano-Frankivsk 707471,
UkraineActive - Recruiting
Climb Investigative Site
Kyiv,
UkraineActive - Recruiting
Climb Investigative Site #2380203
Kyiv,
UkraineActive - Recruiting
Climb Investigative Site #380202
Kyiv,
UkraineActive - Recruiting
Climb Investigative Site #380206
Kyiv,
UkraineSite Not Available
Climb Investigative Site #2380203
Kyiv 703448,
UkraineActive - Recruiting
Climb Investigative Site #380202
Kyiv 703448,
UkraineActive - Recruiting
Climb Investigative Site #380206
Kyiv 703448,
UkraineActive - Recruiting
Climb Investigative Site
Lviv,
UkraineActive - Recruiting
Climb Investigative Site #380201
Lviv,
UkraineSite Not Available
Climb Investigative Site #380201
Lviv 702550,
UkraineActive - Recruiting

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