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Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501

NCT01355289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2018-02-22

Study results available
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Summary

To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.

Conditions

Interventions

DRUG

Avatrombopag

DRUG

Placebo

DRUG

Pegylated interferon (PEG-IFN)

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor.

DRUG

Telaprevir

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor

DRUG

Ribavirin

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Alireza Manhuchehri · 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
2011-11-30
Primary Completion
2014-02-28
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01355289 on ClinicalTrials.gov