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Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic ITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00625443
First received: February 19, 2008
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to determine the safety and efficacy of AKR-501 administered in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
 Drug: Blinded (AKR-501 tablets or placebo)
Drug: Open Label (AKR-501 tablets)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To assess the safety and tolerability of AKR-501 administered for an additional 6 months in patients with chronic ITP who completed 28 days of treatment in Protocol 501-CL-003. [ Time Frame: Day 1 thru Month 6 while receiving treatment and at Month 7 after discontinuation of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate markers of effectiveness, including changes in and maintenance of the peripheral platelet count. [ Time Frame: Day 1 thru Month 6 while receiving treatment and at Month 7 after discontinuation of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: May 2007
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AKR-501 or placebo (double-blind) Drug: Blinded (AKR-501 tablets or placebo)

Placebo, 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
Experimental: AKR-501 tablets (open-label) Drug: Open Label (AKR-501 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

Detailed Description:

Patients 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. Patients 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:

  • AKR-501 2.5 mg daily
  • AKR-501 5 mg daily
  • AKR-501 10 mg daily
  • AKR-501 20 mg daily
  • Placebo

Patients 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 AKR-501 10 mg daily.

This is a parallel group, rollover study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625443

Locations
United States, California
Pacific Cancer Medical Center, Inc
Anaheim, California, United States, 92801
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
United States, Connecticut
Davis, Posteraro and Wasser, MDs, LLP
Manchester, Connecticut, United States, 06105
United States, Florida
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology
Chicago, Illinois, United States, 60612
United States, Indiana
Cancer Care Center, Inc.
New Albany, Indiana, United States, 47150
United States, Missouri
Capitol Comprehensive Cancer Care Clinic
Jefferson, Missouri, United States, 65109
Kansas City Cancer Center, LLC
Kansas City, Missouri, United States, 64131
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Presbyterian Hospital, Weill Medical College of Cornell University
New York, New York, United States, 10032
United States, North Carolina
Emerywood Oncology and Hematology
High Point, North Carolina, United States, 27262
United States, Ohio
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Pei-Ran Ho, MD Eisai Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pei-Ran Ho, MD, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00625443     History of Changes
Other Study ID Numbers: AKR-501-CL-004
Study First Received: February 19, 2008
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Idiopathic Thrombocytopenic Purpura
ITP
Chronic Idiopathic Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
 Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on May 23, 2013