CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 53 enrolled
Drug / intervention
Anagrelide Hydrochloridedrug
Likely dose
Anagrelide Hydrochloride 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01214915
NCT01214915Phase 3Completed
CompareCT.gov

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

Shire·interventional·Posted Oct 5, 2010·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating Anagrelide Hydrochloride for Essential Thrombocythemia (ET). Completed, enrolled 53 participants across 19 sites.

Detailed Summary

The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Thrombocythemia (ET)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2010
Enrollment StartOct 27, 2010
Primary CompletionOct 24, 2012
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.7 years ago

Interventions

Anagrelide Hydrochloridedrug

Subjects will be started at 1.0 mg per day and titrated as necessary.