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

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ClinicalTrials.gov Identifier: NCT00909584
Recruitment Status : Terminated (Study TLK199.2103 was terminated for business reasons.)
First Posted : May 28, 2009
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Telik

May 26, 2009
May 28, 2009
November 25, 2013
April 2009
May 2013   (Final data collection date for primary outcome measure)
Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ]
Same as current
Complete list of historical versions of study NCT00909584 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Severe Chronic Neutropenia
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)
Other Names:
  • Telintra tablets
  • TLK199 Tablets
  • Experimental: 1
    4-Week dose equilibration period with Telintra followed by 4 month treatment period
    Intervention: Drug: Ezatiostat Hydrochloride
  • No Intervention: 2
    4 Month observation period with standard of care treatment and option to crossover to Telintra treatment for 4 week dose equilibration followed by 4 week treatment period
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
20
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed Idiopathic Severe Chronic Neutropenia
  • ECOG performance status of 0-2
  • Adequate liver and renal function
  • Adequate Red Blood Cell and Platelet counts

Exclusion Criteria:

  • Prior treatment of SCN
  • Non-Idiopathic types of SCN, ie. cyclic, congenital
  • History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
  • Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
  • History of bone marrow transplantation or stem cell support
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00909584
TLK199.2103
No
Not Provided
Not Provided
Telik
Telik
Not Provided
Study Director: Gail Brown, MD Telik
Telik
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP