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

Kissei

Status and phase: Completed; Phase 3

Conditions: Idiopathic Thrombocytopenic Purpura

Treatments: Drug: Placebo; Drug: R788

Study type: Interventional

Funder types: Industry

Identifiers

NCT04132050

R788-1301

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

R788

Experimental group

Description:

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).

Treatment:

Drug: R788

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: R788

Drug: Placebo