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Corticosteroid

Ianalumab + Corticosteroids for Low Platelet Count (VAYHIT1 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

VAYHIT1 Trial Summary

This trial studies two doses of ianalumab to see if they can help maintain platelet counts in adults with primary ITP.

Who is the study for?
Adults diagnosed with primary ITP within the last 3 months, having a platelet count below 30 G/L before treatment, and who've responded to corticosteroids can join. Excluded are those with other blood disorders, neutrophil counts below 1.0 G/L, life-threatening bleeding, previous ITP treatments (other than specific first-line therapies), or use of B-cell depleting therapy.Check my eligibility
What is being tested?
The trial is testing two doses of Ianalumab versus a placebo in combination with corticosteroids to see if they help maintain platelet counts above 30 G/L in adults with primary ITP. Participants will be randomly assigned to receive either Ianalumab or a placebo.See study design
What are the potential side effects?
Ianalumab may cause side effects such as infections due to immune system suppression, infusion reactions similar to allergic responses, fatigue, headaches and potentially impact liver function. Corticosteroids can also have multiple side effects like increased appetite, mood changes and higher blood sugar levels.

VAYHIT1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to treatment failure (TTF)
Secondary outcome measures
Change from baseline in ITP-PAQ domain scores
Change from baseline in absolute number of CD19+ B cell counts
Change from baseline in frequency of CD19+ B cell counts
+21 more

VAYHIT1 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ianalumab Lower doseExperimental Treatment2 Interventions
Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Group II: Ianalumab Higher doseExperimental Treatment2 Interventions
Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)
Group III: PlaceboPlacebo Group2 Interventions
Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,129 Total Patients Enrolled

Media Library

Corticosteroids (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05653349 — Phase 3
Thrombocytopenic Purpura Research Study Groups: Ianalumab Lower dose, Placebo, Ianalumab Higher dose
Thrombocytopenic Purpura Clinical Trial 2023: Corticosteroids Highlights & Side Effects. Trial Name: NCT05653349 — Phase 3
Corticosteroids (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653349 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration approved higher dosages of ianalumab?

"The safety of Ianalumab Higher dose is estimated to be 3, as there are multiple studies that have shown its efficacy and evidence supporting its security."

Answered by AI

How many enrollees has this trial recruited so far?

"Affirmative. Records hosted on clinicaltrials.gov verify that this scientific trial, which was first posted on March 6th 2023, is actively enrolling participants. Approximately 225 people need to be enrolled from 33 different medical facilities."

Answered by AI

Are there a significant number of medical sites that are currently running this trial within the state?

"The trial is currently being conducted at 33 sites, located in Gralum, Madrid and Selangor among other places. To reduce the strain of travelling during enrollment, it would be most beneficial to pick a clinic nearest your location."

Answered by AI

Are there still opportunities to join this clinical investigation?

"Affirmative, the information provided on clinicaltrials.gov reveals that this particular research endeavour is currently seeking participants. The trial was initially announced on March 6th 2023 and has since been amended for clarity on May 3rd of the same year. In total, 225 patients are being recruited from 33 distinct locations."

Answered by AI

Who else is applying?

What site did they apply to?
INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
2023. "Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05653349.
All > Thrombocytopenia
~127 spots leftby Sep 2025
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