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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 26, 2009
First Posted Date  ICMJE May 28, 2009
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Severe Chronic Neutropenia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2009)
20
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909584
Other Study ID Numbers  ICMJE TLK199.2103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Telik
Study Sponsor  ICMJE Telik
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gail Brown, MD Telik
PRS Account Telik
Verification Date November 2013

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