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Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
This study has been completed.
Study NCT00039910   Information provided by Pfizer
First Received: June 14, 2002   Last Updated: May 3, 2007   History of Changes

June 14, 2002
May 3, 2007
July 2000
 
To evaluate the effectiveness of primary prophylaxis with intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy-induced thrombocytopenia.
Same as current
Complete list of historical versions of study NCT00039910 on ClinicalTrials.gov Archive Site
  • Identify the effect of rhTPO on the number of platelet transfusions
  • Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis
  • Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
  • Assess the likelihood that patients were to have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycles
  • Assess the safety of multiple IV doses of rhTPO
  • Determine the occurrence and clinical implications of any anti-TPO antibodies
  • Assess the antitumor activity of DHAP chemotherapy
  • Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
  • Evaluate the impact of rhTPO prophylaxis on patient quality of life
Same as current
 
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy

Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.

 
Phase III
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Non-Hodgkin Lymphoma
  • Hodgkin Disease
  • Thrombocytopenia
Drug: (PN-152,243)/ PN-196,444
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
240
March 2003
 

Inclusion Criteria:

  • Patients must have recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease and be scheduled for a minimum of 2 cycles of DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy

Exclusion Criteria:

  • Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Greece,   Hong Kong,   Poland,   Russian Federation,   Singapore
 
NCT00039910
 
444-ONC-0003-0019
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2006

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