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
  Purpose

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
tablet

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01129024

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

No publications provided

Responsible Party: Shionogi Clinical Trials Administrator, Shionogi
ClinicalTrials.gov 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.:
Thrombocytopaenia
Immune Thrombocytopenia (ITP)
Splenectomy
Low Platelet Count
Thrombopoiesis
Idiopathic Thrombocytopenic Purpura
Thrombotic Thrombocytopenic Purpura (ITP)
Hematologic Disease
Auto-immune Thrombocytopenic Purpura
S-888711
Blood Platelet Disorders
Relapsed Persistent or Chronic ITP
ITP

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014