Know Cancer

or
forgot password

A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment


Phase 3
20 Years
N/A
Not Enrolling
Both
Thrombocythemia, Essential

Thank you

Trial Information

A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment


Inclusion Criteria:



- Subjects must have previously been treated with a cytoreductive therapy and been
intolerant or refractory to that therapy.

Exclusion Criteria:

- Subjects should not have any other underlying conditions or medications that would
confound the study analysis or interact with the study medication.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Platelet count

Outcome Description:

At least monthly, efficacy will not be determined until subjects have receive at least 3 months of treatment.

Outcome Time Frame:

Monthly

Safety Issue:

Yes

Principal Investigator

Kanakura, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Osaka University Hospital

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

SPD422-308

NCT ID:

NCT01214915

Start Date:

November 2010

Completion Date:

October 2012

Related Keywords:

  • Thrombocythemia, Essential
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location