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A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132050
Recruitment Status : Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : March 23, 2022
Sponsor:
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 15, 2019
First Posted Date  ICMJE October 18, 2019
Last Update Posted Date March 23, 2022
Actual Study Start Date  ICMJE December 24, 2019
Actual Primary Completion Date December 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
Percentage of patients with stable platelet response [ Time Frame: 24 weeks ]
Percentage of patients with a stable platelet response by Week 24 defined as a platelet count of ≥ 50000/μL on at least 4 of 6 visits between Week 14 to Week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
  • Percentage of patients with overall response [ Time Frame: 12 weeks ]
    Percentage of patients with a platelet count ≥50000/μL on at least 1 of 6 visits from Week 2 to Week 12
  • Duration of maintained platelet count [ Time Frame: 52 weeks ]
    Duration of maintained platelet count since first achievement of a platelet count ≥50000/μL after administration of the study drug
  • Percentage of patients with a platelet count ≥50000/μL [ Time Frame: Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years ]
    Percentage of patients with a platelet count ≥50000/μL at the specified evaluation time point
  • Percentage of patients with a platelet count increase ≥20000/μL above baseline and ≥30000/μL [ Time Frame: Every 2 weeks up to Week 24, every 4 weeks up to Week 52 and every 8 weeks up to 3 years ]
    Percentage of patients with a platelet count increase ≥20000/μL above baseline and ≥30000/μL at the specified evaluation time point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Official Title  ICMJE A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788
Brief Summary The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Thrombocytopenic Purpura
Intervention  ICMJE
  • Drug: R788
    Oral administration
  • Drug: Placebo
    Oral administration
Study Arms  ICMJE
  • Experimental: R788
    Patients are administered R788 for 24 weeks (double-blind period), followed by R788 for up to 52 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).
    Intervention: Drug: R788
  • Placebo Comparator: Placebo
    Patients are administered Placebo for 24 weeks (double-blind period), followed by R788 for up to 28 weeks (open-label period). Patients who have completed open-label period and meet the criteria are eligible to continue R788 treatment over a 3 year period (extension - period).
    Interventions:
    • Drug: R788
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Actual Primary Completion Date December 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Japanese patients
  • Patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent
  • Patients with a platelet count averages <30000/μL during screening period. Each platelet count should not exceed 35000/μL.
  • Patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of ITP before informed consent (with or without splenectomy)

Exclusion Criteria:

  • Patients with thrombocytopenia associated with other disease
  • Patients with autoimmune hemolytic anemia
  • Patients with poorly controlled hypertension
  • Patients with a history or active coagulopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04132050
Other Study ID Numbers  ICMJE R788-1301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kissei Pharmaceutical Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yoshitaka Shimizu Kissei Pharmaceutical Co., Ltd.
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date April 2021

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