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Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)

NCT00441090 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-03-07

Study results available
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Summary

The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).

Conditions

  • Chronic Idiopathic Thrombocytopenic Purpura
  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

Placebo

Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.

DRUG

Avatrombopag tablets

Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Pei-Ran Ho, MD · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441090 on ClinicalTrials.gov