Phase 2
Completed N=53
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
Source: ClinicalTrials.gov NCT00625443 ↗Enrolled (actual)
53
Serious AEs
17.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 12; 24; 14; 4 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
12; 24; 14; 4; 7; 6 | — |
| PRIMARY Incidence of Severe (Grade 3 or 4) TEAEs |
1; 2; 4; 0; 0; 1 | — |
| PRIMARY Incidence of Drug-Related TEAEs |
1; 2; 0; 0; 1; 1 | — |
| SECONDARY Median Platelet Counts at Selected Analysis Timepoints |
55.0; 23.5; 126.0; 54.5; 113.0; 38.0 | — |
| SECONDARY Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit |
59.1; 25.0; 58.3; 18.5; 52.4; 15.4 | — |
| SECONDARY Percentage of Participants Who Maintained a Platelet Count of 100,000/mm^3 or Higher by Response Status |
32.0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit |
86.4; 53.6; 79.2; 44.4; 90.5; 46.2 | — |
| SECONDARY Percentage of Participants Who Maintained Response-Level Platelet Count |
56.0; 0 | — |
| SECONDARY Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response |
72.0; 35.7; 16.0; 28.6; 88.0; 64.3 | — |
| SECONDARY Number of Participants With Changes in Concomitant Steroid Use |
4; 4; 7; 6 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00625443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.