Trials / Terminated
TerminatedNCT00909584
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Telik · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2009-05-28
- Last updated
- 2013-11-25
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00909584. Inclusion in this directory is not an endorsement.