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Drug Use Investigation for REVOLADE (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: NCT01416311
Recruitment Status : Active, not recruiting
First Posted : August 15, 2011
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.

<Priority investigation item> Thromboembolism


Condition or disease Intervention/treatment
Purpura, Thrombocytopaenic, Idiopathic Drug: Eltrombopag

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
Study Start Date : December 21, 2010
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : October 20, 2020


Group/Cohort Intervention/treatment
Subjects prescribed REVOLADE
Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period
Drug: Eltrombopag



Primary Outcome Measures :
  1. The number of subjects with any adverse events treated with REVOLADE [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Appearance of thromboembolism [ Time Frame: 1 year ]
    If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE
Criteria

Inclusion Criteria:

  • Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

  • Not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416311


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01416311    
Other Study ID Numbers: 114877
CETB115B1401 ( Other Identifier: Novartis )
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases