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An Open-label Safety Study of S-888711

This study has been completed.
Sponsor:
Information provided by:
Shionogi Inc.
ClinicalTrials.gov Identifier:
NCT01129024
First received: May 7, 2010
Last updated: May 15, 2012
Last verified: May 2012
History of Changes

May 7, 2010
May 15, 2012
March 2010
August 2011   (final data collection date for primary outcome measure)
To evaluate the long-term safety of S-888711 [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
By measuring the number of study participants with AEs as an indication of drug safety and tolerability
Same as current
Complete list of historical versions of study NCT01129024 on ClinicalTrials.gov Archive Site
  • To assess dose requirements for long-term platelet response [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
  • To assess durability of platelet response [ Time Frame: up to three years ] [ Designated as safety issue: No ]
  • To evaluate bleeding events by World Health Organization (WHO) bleeding criteria [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    Evaluation will utilize World Health Organization (WHO) bleeding criteria
  • To evaluate the long-term platelet response to drug dose [ Time Frame: Up to three years ] [ Designated as safety issue: No ]
  • To evaluate the long-term platelet response to study drug [ Time Frame: up to three years ] [ Designated as safety issue: No ]
  • To evaluate bleeding events during study [ Time Frame: up to three years ] [ Designated as safety issue: No ]
    Evaluation will utilize World Health Organization (WHO) bleeding criteria
Not Provided
Not Provided
 
An Open-label Safety Study of S-888711
An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy

This is a Phase 2, multicenter, open-label, dose-ranging, parallel-group extension study to evaluate the safety of S-888711 in the treatment of subjects with immune thrombocytopenia. Patients who participate in this study must have completed the Phase 2 double-blind, randomized controlled study.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Immune Thrombocytopenia
Drug: 0.5 mg of S-888711
tablet
Experimental: S-888711
Intervention: Drug: 0.5 mg of S-888711
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Not Provided
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A signed and dated written informed consent
  • Males and females ≥ 18 years of age
  • All subjects must agree to use barrier contraception
  • Diagnosis of ITP
  • Subjects > 60 years must have had a diagnostic bone marrow aspiration
  • Relapsed persistent or chronic ITP status
  • Subjects receiving steroid therapy must be on a stable dose
  • PT and APTT within 20% of the upper limit of normal
  • Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed

Exclusion Criteria:

  • History of clinically important hemorrhagic clotting disorder
  • Females who are pregnant, lactating, or taking oral contraceptives
  • History of alcohol/drug abuse or dependence within 1 year

  • Use of the following drugs or treatment prior to Visit 1 (Day 1):

    • Within 1 week - Rho(D) immune globulin or intravenous immunoglobulin;
    • Within 2 weeks - plasmaphoresis treatment;
    • Within 4 weeks - use of anti-platelet or anti-coagulant drugs;
    • Within 8 weeks - rituximab;
    • Within 12 weeks - alemtuzumab, multi-drug systemic chemotherapy, stem cell therapy;
  • History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Initial Screening
  • Splenectomy within 4 weeks prior to Initial Screening

  • Clinically significant laboratory abnormalities

    • Hemoglobin < 10.0 g/dL for men or women, not clearly related to ITP
    • Absolute neutrophil count < 1000/mm3
    • Abnormal peripheral blood smear with evidence of fibrosis confirmed by bonemarrow biopsy
    • Total bilirubin > 1.5 x upper limit of normal
    • Alanine aminotransferase (ALT) > 1.5 x upper limit of normal
    • Aspartate aminotransferase (AST) > 1.5 x upper limit of normal
    • Creatinine > 1.5 x upper limit of normal
    • Human immunodeficiency virus positive
    • Hepatitis A IgM antibody positive, hepatitis B surface antigen or hepatitis C antibody positive
  • Exposure to previous TPO mimetics/agonists (e.g., eltrombopag,romiplostim, E5501 [AKR-501] or LGD-4665) within 4 weeks prior to Initial Screening
  • Subjects unresponsive to previous TPO mimetics/agonists (e.g., eltrombopag, romiplostim, E5501 [AKR-501] or LGD-4665)
  • Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129024
0914M0622
No
Shionogi Clinical Trials Administrator, Shionogi
Shionogi
Not Provided
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
Shionogi Inc.
May 2012

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