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Neuraminidase Inhibitor
Proof-of-Concept: A Pilot, Randomized, Double-Blind Study of Oseltamivir Versus Placebo for Immune Thrombocytopenia
Phase 3
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and day 14
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial is testing oseltamivir, a flu medication, to see if it can help adults with a condition that affects blood platelets. Oseltamivir is commonly used to reduce the duration of flu symptoms. The goal is to find out if oseltamivir can improve platelet function with fewer side effects than current treatments. If successful, this could lead to better long-term health outcomes for these patients.
Eligible Conditions
- Thrombocytopenic Purpura
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 and day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean platelet glycoprotein sialyation
Secondary study objectives
Anti-platelet glycoprotein antibody specificity/titer
Cytokine profiles
Effects of antibodies on macrophage- and hepatocyte-mediated Fc-dependent and independent phagocytosis in vitro
+8 moreSide effects data
From 2018 Phase 4 trial • 184 Patients • NCT018504462%
Dysgeusia
1%
Photophobia
1%
Flatulence
1%
Nausea
1%
Paraesthesia
1%
Chest pain
1%
Hyperthermia
1%
Insomnia
1%
Oropharyngeal pain
1%
Bronchitis
1%
Pruritus
1%
Autonomic nervous system imbalance
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ergoferon (1 Tablet 3 Times a Day)
Oseltamivir (Tamiflu) - 1 Capsule (75mg) Two Times a Day
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OseltamivirExperimental Treatment1 Intervention
Oseltamivir capsule administered orally at 75 mg twice daily for five consecutive days.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule administered orally twice daily for five consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oseltamivir
FDA approved
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
559 Previous Clinical Trials
455,416 Total Patients Enrolled
Li Ka Shing Knowledge InstituteUNKNOWN
2 Previous Clinical Trials
999 Total Patients Enrolled
University of TorontoOTHER
721 Previous Clinical Trials
1,115,229 Total Patients Enrolled