A Phase 3 interventional study of PN-152,243)/PN-196,444 in Sarcoma, sponsored by Pfizer. Completed at 6 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
1,691 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 120 is above the median of 40 across 1,300 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
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 hematological 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 AI chemotherapy.
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
Evaluate the impact of rhTPO prophylaxis on patient quality of life.
Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration
The record gives a start of Sep 2000 and a completion of Mar 2003. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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