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Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia

NCT00909584 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-11-25

No results posted yet for this study

Summary

This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.

Conditions

  • Severe Chronic Neutropenia

Interventions

DRUG

Ezatiostat Hydrochloride

Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)

Sponsors & Collaborators

  • Telik

    lead INDUSTRY

Principal Investigators

  • Gail Brown, MD · Telik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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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 NCT00909584 on ClinicalTrials.gov