Drug Use Investigation for REVOLADE (ITP)

Purpura, Thrombocytopaenic, Idiopathic Clinical Trial

Official title:

Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416311
• Other study ID #: 114877
• Secondary ID: CETB115B1401
• Status: Completed
• Start date: December 21, 2010
• Est. completion date: October 16, 2020

Study information

• Verified date: November 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5797
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopaenic, Idiopathic
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Eltrombopag

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with any adverse events treated with REVOLADE		1 year
Secondary	Appearance of thromboembolism	If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period	1 year