Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: Idiopathic Thrombocytopenic Purpura ITP Chronic Idiopathic Thrombocytopenic Purpura
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).

Detailed description:
Participants eligible to enroll into this rollover protocol will begin study treatment within 2-5 days of their Day 28 study termination visit in Protocol 501-CL-003 (NCT00441090). Participants who met the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the same study treatment to which they were assigned in the previous protocol in a double-blinded manner, these being one of the following 5 treatments:

* avatrombopag 2.5 mg daily
* avatrombopag 5 mg daily
* avatrombopag 10 mg daily
* avatrombopag 20 mg daily
* placebo

Participants who did not meet the primary efficacy response criterion in Protocol 501-CL-003 who otherwise meet the eligibility criteria for this rollover protocol will be offered open label avatrombopag 10 mg daily.

This is a parallel group, rollover study.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Blinded (placebo) intervention 2: Open Label (Avatrombopag tablets) intervention 3: Blinded (Avatrombopoag tablets)
Intervention descriptions: intervention 1: Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months intervention 2: Dose 10 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months intervention 3: Dose: 2.5, 5, 10, or 20 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Protocol document: