Givinostat

Generic Name
Givinostat
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C24H27N3O4
CAS Number
497833-27-9
Unique Ingredient Identifier
5P60F84FBH
Background

Givinostat has been used in trials studying the treatment of Polycythemia Vera, Juvenile Idiopathic Arthritis, Duchenne Muscular Dystrophy (DMD), Chronic Myeloproliferative Neoplasms, and Polyarticular Course Juvenile Idiopathic Arthritis.

Associated Conditions
-
Associated Therapies
-

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2023-10-23
Last Posted Date
2024-12-06
Lead Sponsor
Italfarmaco
Target Recruit Count
220
Registration Number
NCT06093672
Locations
🇺🇸

VA Puget Sound Health Care System - NAVREF - PPDS, Seattle, Washington, United States

🇺🇸

The Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

and more 73 locations

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2023-07-06
Last Posted Date
2024-12-09
Lead Sponsor
Italfarmaco
Target Recruit Count
138
Registration Number
NCT05933057
Locations
🇧🇪

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

🇨🇦

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

🇨🇦

The University of Western Ontario - Children's Health Research Institute, London, Ontario, Canada

and more 17 locations

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2023-05-16
Last Posted Date
2023-05-16
Lead Sponsor
Italfarmaco
Target Recruit Count
8
Registration Number
NCT05860114
Locations
🇵🇹

Hospital da Prelada, 3rd Floor & East Wing 4th Floor Rua Sarmento de Beires, Porto, Portugal

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2023-05-06
Last Posted Date
2024-08-16
Lead Sponsor
Italfarmaco
Target Recruit Count
20
Registration Number
NCT05845567
Locations
🇵🇹

Hospital da Prelada, 3rd Floor & East Wing 4th Floor Rua Sarmento de Beires, Porto, Portugal

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Phase 2
Conditions
Interventions
First Posted Date
2017-12-14
Last Posted Date
2023-11-07
Lead Sponsor
Italfarmaco
Target Recruit Count
206
Registration Number
NCT03373968
Locations
🇮🇹

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica, Milan, Italy

🇫🇷

CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest, Nantes, France

🇬🇧

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Gobowen, United Kingdom

and more 36 locations

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-08-03
Last Posted Date
2024-11-18
Lead Sponsor
Italfarmaco
Target Recruit Count
51
Registration Number
NCT03238235
Locations
🇳🇱

Leiden University Medical Center LUMC, Leiden, Netherlands

🇮🇹

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS, Milan, Italy

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-08-02
Last Posted Date
2023-02-02
Lead Sponsor
Italfarmaco
Target Recruit Count
179
Registration Number
NCT02851797
Locations
🇺🇸

Neuromuscular Research Center UC Davis Department of Physical Medicine and Rehabilitation, Davis, California, United States

🇺🇸

Rady Children's Hospital center - UCSD Department of Neuroscience, San Diego, California, United States

🇺🇸

Child Health Research Institute - Department of Pediatrics, Gainesville, Florida, United States

and more 39 locations

A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-07-17
Last Posted Date
2019-07-30
Lead Sponsor
Italfarmaco
Target Recruit Count
48
Registration Number
NCT01901432
Locations
🇫🇷

Hôpital Saint-Louis (AP-HP), Centre Investigations Cliniques, Paris Cedex 10, France

🇵🇱

Uniwersyteckie Centrum Kliniczne, Gdansk, Poland

🇮🇹

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, BG, Italy

and more 22 locations

Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2013-01-07
Last Posted Date
2024-03-29
Lead Sponsor
Italfarmaco
Target Recruit Count
90
Registration Number
NCT01761968
Locations
🇩🇪

Universitaetsklinikum Freiburg, Innere Medizin I - Haematologie und Onkologie, Freiburg, Germany

🇮🇹

Azienda Ospedaliero-Universitaria Policlinico Consorziale, Bari, Bari, BA, Italy

🇩🇪

Charite Research Organization GmbH, Berlin, Germany

and more 12 locations

A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-01-04
Last Posted Date
2023-11-07
Lead Sponsor
Italfarmaco
Target Recruit Count
20
Registration Number
NCT01761292
Locations
🇮🇹

IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milano, Italy

🇮🇹

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina, Italy

🇮🇹

Ospedale Pediatrico Bambino Gesù, Rome, Italy

and more 1 locations
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