CompletedPhase 3

Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

United States123 participantsStarted 2014-10

Plain-language summary

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response. * Able and willing to give written informed consent Exclusion Criteria: * Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response * Poorly controlled hypertension during Study C935788-047 or Study C935788-048 * Significant infection, an acute infection such as influenza, or known inflammatory process

What they're measuring

Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1

Timeframe: Up to 12 months

Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2

Timeframe: Up to 12 months

Trial details

NCT IDNCT02077192

SponsorRigel Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-02

Results submitted2023-07-25

View on ClinicalTrials.gov More Immune Thrombocytopenic Purpura trials