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

NCT ID: NCT00625443

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-10-31

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 and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).

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 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.

Conditions

Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo (double-blind)

Group Type: EXPERIMENTAL

Blinded (placebo)

Intervention Type: DRUG

Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Avatrombopag tablets (open-label)

Group Type: EXPERIMENTAL

Open Label (Avatrombopag tablets)

Intervention Type: DRUG

Dose 10 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Avatrombopag tablets (double-blind)

Group Type: EXPERIMENTAL

Blinded (Avatrombopoag tablets)

Intervention Type: DRUG

Dose: 2.5, 5, 10, or 20 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Interventions

Blinded (placebo)

Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Intervention Type: DRUG

Open Label (Avatrombopag tablets)

Dose 10 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Intervention Type: DRUG

Blinded (Avatrombopoag tablets)

Dose: 2.5, 5, 10, or 20 mg

Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack)

Duration - 6 months

Intervention Type: DRUG

Other Intervention Names

AKR-501; E5501; YM477; AKR-501; E5501; YM477

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Ran Ho, MD

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Pacific Cancer Medical Center, Inc

Anaheim, California, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Davis, Posteraro and Wasser, MDs, LLP

Manchester, Connecticut, United States

Florida Cancer Institute

New Port Richey, Florida, United States

John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology

Chicago, Illinois, United States

Cancer Care Center, Inc.

New Albany, Indiana, United States

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, United States

Kansas City Cancer Center, LLC

Kansas City, Missouri, United States

Mount Sinai Medical Center

New York, New York, United States

New York Presbyterian Hospital, Weill Medical College of Cornell University

New York, New York, United States

Emerywood Oncology and Hematology

High Point, North Carolina, United States

Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center

Columbus, Ohio, United States

Countries

United States

References

Bussel JB, Kuter DJ, Aledort LM, Kessler CM, Cuker A, Pendergrass KB, Tang S, McIntosh J. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014 Jun 19;123(25):3887-94. doi: 10.1182/blood-2013-07-514398. Epub 2014 May 6.

Reference Type: DERIVED

PMID: 24802775 (View on PubMed)

Other Identifiers

AKR-501-CL-004

Identifier Type: -

Identifier Source: org_study_id