Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Blinded (placebo); Open Label (Avatrombopag tablets); Blinded (Avatrombopoag tablets)
Intervention description: 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; 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; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Idiopathic Thrombocytopenic Purpura; ITP; Chronic Idiopathic Thrombocytopenic Purpura

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who completed 28 days of study treatment in Protocol 501-CL-003.

          2. No significant safety or tolerability concerns from the patient's participation of
             Protocol 501-CL-003 as determined by the Investigator.

          3. Received medical monitor approval for enrollment into this study.

          4. Patients receiving maintenance corticosteroids may be enrolled, as long as the
             corticosteroids have been administered at a stable dose and the Investigator does not
             foresee the need to change the steroid dose during study participation. Patients
             should remain on this stable corticosteroid dose during study participation.

          5. Women of child-bearing potential must have a negative serum pregnancy test at the Day
             28 assessment in Protocol 501-CL-003. (Childbearing potential is defined as any woman
             who has not been surgically sterilized and is pre-menopausal or peri-menopausal i.e.,
             any menstrual flow within 12 months of Screening Visit A for Protocol 501-CL-003).

          6. Women of child-bearing potential must agree to practice a medically approved form of
             contraception (one of the following must be used: condoms (male or female) with a
             spermicidal agent, diaphragm or cervical cap with a spermicidal agent, IUD,hormonal
             contraception, abstinence).

          7. Willing and able to provide written informed consent.

        Exclusion Criteria:

          1. Women who are pregnant and/or lactating.

          2. Use of the following drugs or treatments:

               -  Rituximab

               -  Azathioprine, Cyclosporine A, or other immunosuppressant therapy

               -  Aspirin, Aspirin-containing compounds, Salicylates,Anticoagulants, Non-steroidal
                  anti-inflammatory drugs(NSAIDs)(including Cyclooxygenase-2 [COX-2] specific
                  NSAIDs), clopidogrel; ticlopidine; and any drugs that affect platelet function.

               -  Danazol

               -  Rh0(D) immune globulin (WinRho®) or intravenous immunoglobulin (IVIG).

          3. Inability to comply with protocol requirements or give informed consent, as determined
             by the Investigator.

        For more information regarding inclusion/exclusion criteria, please see record for AKR
        501-CL-003 Protocol.