Status:
COMPLETED
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
Lead Sponsor:
Eisai Inc.
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 a...
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 me...
Eligibility Criteria
Inclusion
- Patients who completed 28 days of study treatment in Protocol 501-CL-003.
- No significant safety or tolerability concerns from the patient's participation of Protocol 501-CL-003 as determined by the Investigator.
- Received medical monitor approval for enrollment into this study.
- 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.
- 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).
- 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).
- Willing and able to provide written informed consent.
Exclusion
- Women who are pregnant and/or lactating.
- 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).
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00625443
Start Date
May 1 2007
End Date
October 1 2009
Last Update
March 16 2018
Active Locations (12)
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1
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
3
Davis, Posteraro and Wasser, MDs, LLP
Manchester, Connecticut, United States, 06105
4
Florida Cancer Institute
New Port Richey, Florida, United States, 34655