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Thrombopoietin Receptor Agonist

Ianalumab + Eltrombopag for Low Platelet Count (VAYHIT2 Trial)

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
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 at 1 year
Awards & highlights
Pivotal Trial

Summary

This trial tests two doses of ianalumab to see if it can help people with ITP whose first treatment didn't work.

Who is the study for?
Adults over 18 with primary immune thrombocytopenia (ITP) who didn't respond well to steroids can join. They must have a low platelet count and be eligible for eltrombopag treatment. People with coagulation disorders, other cytopenias, significant blood diseases, life-threatening bleeding history, or positive HIV/HCV cannot participate.
What is being tested?
The trial is testing how effective two doses of ianalumab are when added to eltrombopag in prolonging the time before ITP treatment fails after steroid therapy doesn’t work. Participants will either receive ianalumab or a placebo alongside eltrombopag.
What are the potential side effects?
Possible side effects include reactions at the injection site for ianalumab, liver function changes due to eltrombopag, and general symptoms like headaches or fatigue. The exact side effects may vary between individuals.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time from randomization until treatment failure
Secondary study objectives
Best response rate across all timepoints
Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity
Change from baseline in immunoglobulins
+22 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment arm 2Experimental Treatment2 Interventions
Participants will receive eltrombopag and ianalumab higher dose
Group II: Treatment arm 1Experimental Treatment2 Interventions
Participants will receive eltrombopag and ianalumab lower dose
Group III: Treatment arm 3Placebo Group2 Interventions
Participants will receive eltrombopag and placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eltrombopag
2013
Completed Phase 4
~970

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,553 Total Patients Enrolled

Media Library

Eltrombopag (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05653219 — Phase 3
Thrombocytopenic Purpura Research Study Groups: Treatment arm 1, Treatment arm 2, Treatment arm 3
Thrombocytopenic Purpura Clinical Trial 2023: Eltrombopag Highlights & Side Effects. Trial Name: NCT05653219 — Phase 3
Eltrombopag (Thrombopoietin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653219 — Phase 3
~40 spots leftby Aug 2025
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