Drug Use Investigation for REVOLADE (ITP) | NCT01416311

Studies
Drug Use Investigation for REVOLADE (ITP)

NCT01416311

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Nov 20, 2020Actual

Enrollment

5,797Actual

Phase

Not provided

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Interventions

Eltrombopag

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CETB115B1401	Other Identifier	Novartis

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2010Actual

Primary Completion Date

Oct 16, 2020Actual

Completion Date

Oct 16, 2020Actual

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Aug 11, 2011

First Posted Date

Aug 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2020

Last Update Posted Date

Nov 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,797Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects prescribed REVOLADE		Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period	Drug: Eltrombopag

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eltrombopag	Drug		Subjects prescribed REVOLADE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of subjects with any adverse events treated with REVOLADE		1 year

Secondary Outcomes

Measure	Description	Time Frame
Appearance of thromboembolism	If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

Not applicable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011693	Purpura

Ancestor Terms

ID	Term
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006470	Hemorrhage

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520809	eltrombopag

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided