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Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

NCT01557452 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-04-06

Study results available
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Summary

Primary Objective of the study:

the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

Givinostat

ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Pavla Dolezalova, MD · General Faculty Hospital Department of Pediatrics and Adolescent Medicine, Praha, Czech Republic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-28
Primary Completion
2014-01-27
Completion
2014-01-27

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557452 on ClinicalTrials.gov