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NCT01416311 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT00908037 - Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 2
Completed NCT00442871 - Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment Phase 1
Completed NCT01098487 - A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Phase 4
Withdrawn NCT01440361 - A Study to Investigate Belimumab for the Treatment of Chronic Immune Thrombocytopenia. Phase 2
Completed NCT01064336 - Promacta Pregnancy Registry N/A
Completed NCT00424177 - Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) Phase 2
Completed NCT00351468 - EXTEND (Eltrombopag Extended Dosing Study) Phase 3
Completed NCT00688272 - Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag Phase 1
Completed NCT01072162 - Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect Phase 1
Completed NCT00643929 - LENS - Long-term Eltrombopag Observational Study N/A
Completed NCT00102739 - SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP) Phase 2
Completed NCT00359463 - Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment Phase 1