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Histone Deacetylase Inhibitor

Givinostat vs Hydroxyurea 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
No Placebo-Only Group
Pivotal 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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients achieving a response at Week 48.
Secondary study objectives
Proportion of patients achieving a complete hematological response (CHR) at Week 48.

Side effects data

From 2017 Phase 1 & 2 trial • 48 Patients • NCT01901432
57%
Diarrhoea
46%
Thrombocytopenia
40%
Blood creatinine increased
29%
Nausea
29%
Asthenia
23%
Abdominal pain
17%
Anaemia
14%
Hypocalcaemia
14%
Dyspepsia
11%
Abdominal pain upper
11%
Pyrexia
11%
Decreased appetite
11%
Alopecia
9%
Palpitations
9%
Constipation
9%
Dysgeusia
9%
Cough
9%
Pruritus
6%
Thrombocytosis
6%
Blood bilirubin increased
6%
Bone pain
6%
Iron deficiency
6%
Dizziness
6%
Neutropenia
6%
Flatulence
6%
Fatigue
6%
Oedema peripheral
6%
Urinary tract infection
6%
Weight decreased
6%
Hypoaesthesia
6%
Acute kidney injury
6%
Dyspnoea
6%
Dyspnoea exertional
6%
Thrombosis
6%
Hypertension
3%
Pneumonia
3%
Headache
3%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Givinostat at MTD (100 mg b.i.d.) (Part B)
Givinostat DL1 Expanded (100 mg b.i.d.) (Part A)
Givinostat DL6 (100 mg + 50 mg) (Part A)
Givinostat DL0 (50 mg b.i.d.) (Part A)
Givinostat DL1 (100 mg b.i.d.) (Part A)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GivinostatExperimental Treatment1 Intervention
Group II: HydroxyureaActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Givinostat
2013
Completed Phase 2
~150

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
~147 spots leftby Jul 2026
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