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 (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00625443
First received: February 19, 2008
Last updated: October 30, 2013
Last verified: October 2013

February 19, 2008
October 30, 2013
May 2007
June 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00625443 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Idiopathic Thrombocytopenic Purpura
  • 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

  • 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

  • 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

  • Experimental: placebo (double-blind)
    Intervention: Drug: Blinded (placebo)
  • Experimental: AKR-501 tablets (open-label)
    Intervention: Drug: Open Label (AKR-501 tablets)
  • Experimental: AKR-501 tablets (double-blind)
    Intervention: Drug: Blinded (AKR-501 tablets)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
October 2009
June 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00625443
AKR-501-CL-004
No
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Pei-Ran Ho, MD Eisai Inc.
Eisai Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP