Clinical Trial: Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
Brief 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.
Detailed Summary:
Sponsor: Telik
Current Primary Outcome: Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of infections, oropharyngeal ulcers and antibiotic use [ Time Frame: 18 Months ]
- Incidence and duration of hospitalizations [ Time Frame: 18 Months ]
- FACT-N quality of life assessment [ Time Frame: 18 Months ]
- Safety assessments [ Time Frame: 18 Months ]
Original Secondary Outcome: Same as current
Information By: Telik
Dates:
Date Received: May 26, 2009
Date Started: April 2009
Date Completion:
Last Updated: November 20, 2013
Last Verified: November 2013
