A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Conditions

• Immune Thrombocytopenic Purpura

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fostamatinib disodium — DRUG
  Fostamatinib (100 mg PO bid or 150 mg PO bid)
• Placebo — DRUG
  Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Study Details

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Key Dates

Start date

Jul 14, 2014

Status verified

Oct 2018

Primary completion

Apr 21, 2016

Completion

Apr 21, 2016

Study Design

Enrollment

76 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fostamatinib Disodium
  Subjects begin with Fostamatinib Disodium tablet 100 mg PO bid and increase to 150 mg big after week 4 based on platelet count and tolerability.
• Other: Placebo
  Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Primary Outcome Measure

Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) [ Time Frame: From Week 14 to Week 24 ]

Locations (13)

Find similar trials in Tucson, AZ

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