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Trial record 97 of 141 for:    MPL

A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02201290
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Purpura, Thrombocytopenic, Idiopathic
Interventions Drug: Eltrombopag Tablets
Drug: Eltrombopag PfOS
Enrollment 9
Recruitment Details A total of 9 patients received Eltrombapag treatment during the extension study. Four patients (44.4%) completed the study while 5 patients (55.6%) discontinued from treatment and withdrew from the study.
Pre-assignment Details  
Arm/Group Title Eltrombopag
Hide Arm/Group Description treated participants
Period Title: Overall Study
Started 9
Completed 4
Not Completed 5
Reason Not Completed
Withdrawal by Subject             2
Lack of Efficacy             2
Adverse Event             1
Arm/Group Title Eltrombopag
Hide Arm/Group Description all treated participants
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
9.7  (3.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White - Caucasian Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

Frequency of all adverse events (including Ophthalmic events) categorized using CTCAE toxicity grades and clinical laboratory test [ Time Frame: Up to Week 4 Follow-up period ] Clinical laboratory assessments and frequency of all adverse events, categorized using Common Terminology Criteria for Adverse Events (CTCAE) toxicity grades will present safety and tolerability endpoints

Serious Adverse Events are below. See All Adverse Events in the following section for specifics

No statistical analysis was planned for this primary outcome

Time Frame Up to week 4 follow up period
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title Eltrombopag
Hide Arm/Group Description:
Adverse events by system organ class and maximum severity for all treated participants
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Number of subjects with at least one event 3
Scleral haemorrhage 1
Autoimmune hepatitis 1
Epistaxis 1
Time Frame up to week 4
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eltrombopag
Hide Arm/Group Description Eltrombopag was provided to sites by GlaxoSmithKline as tablets or as dry powder for oral suspension (PfOS) sachets
All-Cause Mortality
Eltrombopag
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eltrombopag
Affected / at Risk (%)
Total   3/9 (33.33%) 
Eye disorders   
Scleral haemorrhage  1  1/9 (11.11%) 
Hepatobiliary disorders   
Autoimmune hepatitis  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/9 (11.11%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eltrombopag
Affected / at Risk (%)
Total   6/9 (66.67%) 
Infections and infestations   
Nasopharyngitis  1  3/9 (33.33%) 
Pharyngitis  1  1/9 (11.11%) 
Tonsillitis  1  1/9 (11.11%) 
Investigations   
Blood bilirubin increased  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Iron deficiency  1  1/9 (11.11%) 
Nervous system disorders   
Headache  1  2/9 (22.22%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/9 (11.11%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: (862) 778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02201290     History of Changes
Other Study ID Numbers: 117366
CETB115BRU01 ( Other Identifier: Novartis )
2017-004082-27 ( EudraCT Number )
First Submitted: June 6, 2013
First Posted: July 28, 2014
Results First Submitted: December 14, 2017
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019