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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
VAYHIT2 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.Check my eligibility
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.See study design
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.
VAYHIT2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
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 until treatment failure
Secondary outcome measures
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 moreVAYHIT2 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
2,860 Previous Clinical Trials
4,198,159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ITP and have tried treatments beyond steroids, including having my spleen removed.I have a history of severe bleeding.I have liver problems.I am 18 years or older.I have low blood counts but am eligible if it's due to bleeding or iron deficiency.I am not on blood thinners, except possibly low-dose aspirin.I have a history of significant blood disorders.I am currently pregnant or nursing.My platelet count is below 30G/L and I can take eltrombopag.I am HIV or HCV positive, or have Hepatitis B but with no liver damage and am on antiviral treatment.I have ITP and steroids or IVIG didn't work well for me.I do not have an active or uncontrolled infection needing treatment now.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm 1
- Group 2: Treatment arm 2
- Group 3: Treatment arm 3
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Treatment arm 1?
"Treatment arm 1 has been granted a safety rating of 3 based on the available data from this Phase 3 trial, which suggests both efficacy and multiple confirmations of its security."
Answered by AI
Is this trial presently enlisting volunteers?
"Clinicaltrials.gov's current data shows that this experiment is open to recruitment and was posted on February 2nd, 2023 with the last update taking place on May 24th of the same year."
Answered by AI
What is the cap for participants signing up to join this research protocol?
"Affirmative. Confirmed by clinicaltrials.gov, this medical study is actively recruiting patients since its initial publishing date of February 2nd 2023 and most recent update on May 24th 2023. Currently, 150 individuals are required to be enrolled across 35 sites."
Answered by AI
How many medical facilities are actively taking part in this research initiative?
"Currently, 35 clinical trial sites are enrolling patients. These centres span the globe including Praha 10, Seoul and Narita to name a few. To minimize travel requirements, it is suggested that individuals choose the nearest site for enrolment"
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
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