CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
SPD422 (anagrelide hydrochloride)drug
Likely dose
Not stated in 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/NCT01467661
NCT01467661Phase 3Completed
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A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Shire·interventional·Posted Nov 9, 2011·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating SPD422 (anagrelide hydrochloride) for Essential Thrombocythemia (ET). Completed, enrolled 41 participants across 16 sites.

Detailed Summary

The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2011
Enrollment StartOct 27, 2010
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 14.6 years ago

Interventions

SPD422 (anagrelide hydrochloride)drug

Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.