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A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Phase 2
18 Years
Not Enrolling
Idiopathic Thrombocytopenic Purpura

Thank you

Trial Information

A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Patients 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. Patients 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:

- AKR-501 2.5 mg daily

- AKR-501 5 mg daily

- AKR-501 10 mg daily

- AKR-501 20 mg daily

- Placebo

Patients 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 AKR-501 10 mg daily.

This is a parallel group, rollover study.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of AKR-501 administered for an additional 6 months in patients with chronic ITP who completed 28 days of treatment in Protocol 501-CL-003.

Outcome Time Frame:

Day 1 thru Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.

Safety Issue:


Principal Investigator

Pei-Ran Ho, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2010

Related Keywords:

  • Idiopathic Thrombocytopenic Purpura
  • Idiopathic Thrombocytopenic Purpura
  • ITP
  • Chronic Idiopathic Thrombocytopenic Purpura
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic



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