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
Status: | Completed |
---|---|
Conditions: | Hematology, Hematology, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | May 2007 |
End Date: | October 2009 |
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
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).
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).
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.
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.
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.
We found this trial at
12
sites
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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1900 West Harrison Street
Chicago, Illinois 60612
Chicago, Illinois 60612
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New York, New York 10021
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