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Drug Use Investigation for REVOLADE (ITP)

NCT ID: NCT01416311

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5797 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-21

Study Completion Date

2020-10-16

Brief Summary

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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

Detailed Description

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Conditions

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Purpura, Thrombocytopaenic, Idiopathic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects prescribed REVOLADE

Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period

Eltrombopag

Intervention Type DRUG

Interventions

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Eltrombopag

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CETB115B1401

Identifier Type: OTHER

Identifier Source: secondary_id

114877

Identifier Type: -

Identifier Source: org_study_id