Study Stopped
The study was terminated due to cessation of clinical development of S-888711 for chronic ITP based on a business decision by the Sponsor.
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)
1 other identifier
interventional
19
1 country
19
Brief Summary
The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2010
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2010
CompletedFirst Submitted
Initial submission to the registry
May 7, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2011
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
February 1, 2021
1.2 years
May 7, 2010
February 5, 2021
February 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent. A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.
From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
Secondary Outcomes (5)
Duration of Response
From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on treatment was 148 (10 - 387) days.
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Bleeding assessments were performed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter until end of treatment; median (range) time on treatment was 148 (10-387) days.
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL
Platelets were assessed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter, until end of treatment; median (range) time on treatment was 148 (10-387) days.
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL Without Rescue Medication
Platelets were assessed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter, until end of treatment; median (range) time on treatment was 148 (10-387) days.
Change From Baseline in Platelet Counts at the Final Visit
Baseline and the final visit (If a subject had multiple platelet count measurements for the specific dose level due to dose adjustments, the final platelet count was used)
Study Arms (1)
Lusutrombopag
EXPERIMENTALParticipants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts. If a subject's platelet count remained \< 50,000/μL, the dose could have been increased by 0.25 mg up to a maximum dose of 2.0 mg.
Interventions
Eligibility Criteria
You may qualify if:
- 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, with or without prior splenectomy
- Subjects receiving steroid therapy must be on a stable dose for at least 2 weeks prior to Screening
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) within 20% of the upper limit of normal (ULN) at Screening
- Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shionogilead
Study Sites (19)
Investigator
Anaheim, California, 92801, United States
Investigator
Los Angeles, California, 90272, United States
Investigator
Washington D.C., District of Columbia, 20007, United States
Investigator
Boynton Beach, Florida, 33426, United States
Investigator
Jacksonville, Florida, 32207, United States
Investigator
Atlanta, Georgia, 30341, United States
Investigator
Riverdale, Georgia, 30274, United States
Investigator
Metairie, Louisiana, 70006, United States
Investigator
Bethesda, Maryland, 20817, United States
Investigator
Boston, Massachusetts, 02114, United States
Investigator
Jefferson City, Missouri, 65109, United States
Investigator
Kansas City, Missouri, 64131, United States
Investigator
New Brunswick, New Jersey, 08903, United States
Investigator
New York, New York, 10021, United States
Investigator
New York, New York, 10029, United States
Investigator
Cleveland, Ohio, 44106, United States
Investigator
San Antonio, Texas, 78229, United States
Investigator
Salt Lake City, Utah, 84132, United States
Investigator
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shionogi Clinical Trials Administrator
- Organization
- Shionogi Inc.
Study Officials
- STUDY DIRECTOR
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2010
First Posted
May 24, 2010
Study Start
April 29, 2010
Primary Completion
June 30, 2011
Study Completion
June 30, 2011
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-02