Clinical Trials Actively Recruiting in Canada

Breakdown for each trial:
• Name of trial
• Short summary
• Countries recruiting
• Link to trial page on clinicaltrials.gov
• Trial Status

Safety and Efficacy Study of PF-06835375 in Primary ITP

Pfizer is conducting a phase 2 multicenter study to look at the safety and efficacy of using a drug called PF-06835375 for treatment of adults (between 18-70 years) with persistent or chronic primary ITP. This drug is administered either intravenously or subcutaneously, however in this trial subcutaneous injection would be the method of drug delivery. The drug acts by targeting a C-X-C chemokine receptor type 5 (CXCR5) inhibitor. Eligible participants have on-going ITP with a platelet count less than 50,000.

Canada, USA, Australia, Czechia, Hungary, and Poland

https://classic.clinicaltrials.gov/ct2/show/NCT05070845

Actively Recruiting

An Open-label Study of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4)

Alpine Immune Sciences is conducting a Phase 1b Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of a new treatment for immune thrombocytopenia (and other autoimmune cytopenias) called Povetacicept (also known as APLN-303). This study is open to adults with persistent or chronic ITP. Povetacicept is a is a dual B cell cytokine antagonist engineered to inhibit BAFF (BLyS) and APRIL which are clinically validated cytokine pathways that play a key role in B cell development, differentiation, and survival. The drug will be provided to participants every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period. Adult participants must have shown failure to at least two previous treatments for ITP, including exposure to a TPO-RA, unless otherwise contraindicated or unavailable to them. Participants must also have a documented platelet count of less than 30,000 µL.

Australia, Canada, Turkey, USA

https://www.clinicaltrials.gov/study/NCT05757570?term=%20Povetacicept%20&rank=2

Actively Recruiting

PDSA Patient Consented Natural History Study Registry

This global ITP registry study is FDA approved and developed in partnership with the National Organization for Rare Disorders (NORD) to follow ITP patients of all ages, in all phases of disease to learn more about the natural history of ITP. The goal of the registry is to learn more about the clinical characteristics of ITP, the incidence of co-morbidities, treatment patterns, adverse outcomes, how quality of life is impacted, how family and socioeconomics is affected, and how ITP patients respond to COVID-19 and vaccinations.  Note: The registry is in English only, currently.

USA, Canada, International (all places).

https://www.pdsa.org/registry.html

Recruiting

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP) (LUNA3)

Sanofi is conducting a phase three randomized, double-blind study of rilzabrutinib (previously referred to as PRN1008), and oral BTK inhibitor. They are looking to enroll patients with persistent or chronic ITP who are at least 12 years of age. Eligible patients must have an average platelet count of <30,000/μL on two counts (with no count higher than <35,000/μL) at least 5 days apart in the 14 days before treatment begins. The double-blind treatment period is 12-24 weeks depending on platelet response, followed by a 28-week open label period. Patients who respond to rilzabrutinib may enter a long term-extension. After the last dose of rilzabrutinib there will be a 4-week safety follow-up visit.

Argentina, Austria, Australia, Canada, Chile, France, Germany, Hungary, Israel, Italy, Norway, Poland, Russian Confederation, Singapore, South Korea, Spain, Thailand, Ukraine, UK, and the USA.

https://clinicaltrials.gov/ct2/show/NCT04562766

Recruiting

Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune Thrombocytopenia

This is a randomized double-blind pilot study to determine the clinical utility of using Oseltamirvir compared to placebo in the treatment of ITP. Oseltamivir is an attractive drug for ITP since it specifically targets a pathophysiologic mechanism that appears to be important for the development of ITP and has a benign side effect profile compared to standard ITP therapy. Eligibility includes adults with ITP who have not had a sustained response to other available treatments.

Canada

https://clinicaltrials.gov/ct2/show/NCT03520049?recrs=a&cond=ITP&draw=4

Status: Unknown

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