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Histone Deacetylase Inhibitor

Givinostat for Polycythemia Vera (GIV-IN PV Trial)

Phase 3
Recruiting
Research Sponsored by Italfarmaco
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 week 25 - week 48
Awards & highlights

GIV-IN PV Trial Summary

"This trial aims to see if givinostat is better and safer than hydroxyurea for patients with a specific type of blood disorder called polycythemia vera."

Who is the study for?
This trial is for people over 60 years old or those who've had a blood clot, diagnosed with Polycythemia Vera (PV) within the last 3 years. They must have high white blood cell or platelet counts and test positive for JAK2V617F mutation. Their hematocrit levels should be normalized before joining.Check my eligibility
What is being tested?
The study compares two treatments for PV: Givinostat Hydrochloride and Hydroxyurea, focusing on their effectiveness and safety in patients with a specific genetic marker (JAK2V617F) associated with higher risk of the disease.See study design
What are the potential side effects?
Potential side effects may include digestive issues, headaches, dizziness, skin reactions at injection sites, liver enzyme changes, fatigue, and an increased risk of infections.

GIV-IN PV Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 25 - week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 25 - week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients achieving a response at Week 48.
Secondary outcome measures
Proportion of patients achieving a complete hematological response (CHR) at Week 48.
Proportion of patients with a normal spleen size at Week 48.
Safety and tolerability up to Week 48.
+1 more

GIV-IN PV Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GivinostatExperimental Treatment1 Intervention
Group II: HydroxyureaActive Control1 Intervention

Find a Location

Who is running the clinical trial?

ItalfarmacoLead Sponsor
33 Previous Clinical Trials
4,279 Total Patients Enrolled
2 Trials studying Polycythemia Vera
93 Patients Enrolled for Polycythemia Vera

Frequently Asked Questions

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

Has Givinostat received approval from the FDA?

"The safety evaluation of Givinostat by our team at Power is graded as 3, indicating a high level of safety assurance due to the Phase 3 trial stage with existing efficacy data and robust safety evidence."

Answered by AI

What is the total number of participants being recruited for this research study?

"Indeed, details on clinicaltrials.gov indicate that this study is actively pursuing participants. Initially shared on March 1st, 2024, the trial was last revised on March 5th of the same year. The research aims to enroll 220 individuals at a single designated site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
2024. "Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06093672.
All > Polycythemia Vera
~147 spots leftby Jul 2026
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