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 - Full Text View

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00625443

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 II

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research 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
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AKR-501 or placebo (double-blind): Experimental	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
AKR-501 tablets (open-label): Experimental	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:

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.

Contacts and Locations

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

Contacts

Contact: Eisai Medical Services

1-888-422-4743

Locations

United States, California
Comprehensive Blood and Cancer Center	Recruiting
Bakersfield, California, United States, 93309
Contact: Alan Cartmell
Principal Investigator: Alan Cartmell
Pacific Cancer Medical Center, Inc	Recruiting
Anaheim, California, United States, 92801
Contact: Ajit Maniam
Principal Investigator: Ajit Maniam
United States, Connecticut
Davis, Posteraro and Wasser, MDs, LLP	Recruiting
Manchester, Connecticut, United States, 06105
Contact: Jeffrey Wasser
Principal Investigator: Jeffrey Wasser
United States, Florida
Florida Cancer Institute	Recruiting
New Port Richey, Florida, United States, 34655
Contact: Gerald Robbins
Principal Investigator: Gerald Robbins
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County, Div. of Hematology and Oncology	Recruiting
Chicago, Illinois, United States, 60612
Contact: Rosalind Catchatourian
Principal Investigator: Rosalind Catchatourian
United States, Indiana
Cancer Care Center, Inc.	Recruiting
New Albany, Indiana, United States, 47150
Contact: Chowhan Naveed
Principal Investigator: Muffaddal Morkas
United States, Missouri
Capitol Comprehensive Cancer Care Clinic	Recruiting
Jefferson, Missouri, United States, 65109
Contact: Ali Khojasteh
Principal Investigator: Ali Khojasteh
Kansas City Cancer Center, LLC	Recruiting
Kansas City, Missouri, United States, 64131
Contact: Kelly Pendergrass
Principal Investigator: Kelly Pendergrass
United States, New York
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Louis Aledort, MD
Principal Investigator: Louis Aledort
New York Presbyterian Hospital, Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10032
Contact: James Bussel
Principal Investigator: James Bussel
United States, North Carolina
Emerywood Oncology and Hematology	Recruiting
High Point, North Carolina, United States, 27262
Contact: Bernard Chinnasami
Principal Investigator: Bernard Chinnasami
United States, Ohio
Mid Ohio Oncology/Hematology, Inc., dba The Mark H. Zangmeister Center	Recruiting
Columbus, Ohio, United States, 43219
Contact: Tarek Chidiac
Principal Investigator: Tarek Chidiac

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators

Study Chair:

Akhil Baranwal, MD

MGI Pharma, Inc. - Medical Monitor

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Eisai Medical Research Inc. ( Akhil Baranwal, MD )
Study ID Numbers:	AKR-501-CL-004
Study First Received:	February 19, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00625443
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:

Idiopathic Thrombocytopenic Purpura
ITP
Chronic Idiopathic Thrombocytopenic Purpura

Study placed in the following topic categories:

Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic

Signs and Symptoms
Thrombocytopathy
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:

Skin Manifestations
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009