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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00625443
• Date of registration: 19/02/2008
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: May 2007
• Target sample size: 53
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00625443
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pei-Ran Ho, MD
• Affiliation: Eisai Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Drug: Blinded (placebo)

Drug: Blinded (Avatrombopoag tablets)

Drug: Open Label (Avatrombopag tablets)

Primary Outcome(s)

Incidence of Drug-Related TEAEs [Time Frame: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.]

Incidence of Severe (Grade 3 or 4) TEAEs [Time Frame: Day 1 through Month 6 while receiving treatment and at Month 7 after discontinuation of treatment.]

Secondary Outcome(s)

Percentage of Participants Who Achieved Response-Level Platelet Count by Selected Study Visit [Time Frame: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Percentage of Participants Who Maintained a Platelet Count of 100,000/mm^3 or Higher by Response Status [Time Frame: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Percentage of Participants Who Maintained Response-Level Platelet Count [Time Frame: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Median Platelet Counts at Selected Analysis Timepoints [Time Frame: Day 1, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Number of Participants With Changes in Concomitant Steroid Use [Time Frame: Day 1 through last 8 weeks of the Treatment Period]

Percentage of Participants Who Achieved a Durable, Transient, or Overall Platelet Response [Time Frame: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Percentage of Participants Who Achieved a Platelet Count of 100,000/mm^3 or Higher by Response Status and Selected Study Visit [Time Frame: Baseline (last PC before first dose of study drug in previous study), Weeks 2, 4, 8, 12, 16, 20, 24, and Follow-up Weeks (after last dose of study drug in this study) 1, 2, 3, 4]

Secondary ID(s)

AKR-501-CL-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00625443