An Open-label Safety Study of S-888711

This study has been completed.
Information provided by:
Shionogi Inc. Identifier:
First received: May 7, 2010
Last updated: May 15, 2012
Last verified: May 2012

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.

Condition Intervention Phase
Immune Thrombocytopenia
Drug: 0.5 mg of S-888711
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy

Resource links provided by NLM:

Further study details as provided by Shionogi Inc.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 19
Study Start Date: March 2010
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-888711 Drug: 0.5 mg of S-888711


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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01129024

United States, California
Anaheim, California, United States, 92801
Los Angeles, California, United States, 90272
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Boynton Beach, Florida, United States, 33426
Jacksonville, Florida, United States, 32207
United States, Georgia
Atlanta, Georgia, United States, 30341
Riverdale, Georgia, United States, 30274
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Missouri
Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64131
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
New York, New York, United States, 10029
New York, New York, United States, 10021
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Study Director: Shionogi Clinical Trials Administrator Clinical Support Help Line Shionogi
  More Information

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi Identifier: NCT01129024     History of Changes
Other Study ID Numbers: 0914M0622
Study First Received: May 7, 2010
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Shionogi Inc.:
Low Platelet Count
Idiopathic Thrombocytopenic Purpura
Immune Thrombocytopenia (ITP)
Thrombotic Thrombocytopenic Purpura (ITP)
Hematologic Disease
Auto-immune Thrombocytopenic Purpura
Blood Platelet Disorders
Relapsed Persistent or Chronic ITP

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Purpura, Thrombocytopenic
Signs and Symptoms
Skin Manifestations
Thrombotic Microangiopathies processed this record on October 09, 2015