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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625443
First Posted: February 28, 2008
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  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 (placebo) Drug: Open Label (AKR-501 tablets) Drug: Blinded (AKR-501 tablets) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Eisai Inc.:

Enrollment: 53
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo (double-blind) Drug: 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

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

Experimental: AKR-501 tablets (double-blind) Drug: Blinded (AKR-501 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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00625443     History of Changes
Other Study ID Numbers: AKR-501-CL-004
First Submitted: February 19, 2008
First Posted: February 28, 2008
Last Update Posted: February 24, 2017
Last Verified: February 2017

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