Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00037791
Collaborator
(none)
180
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33
20
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Study Details
Study Description
Brief Summary
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 this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.
Study Start Date
:
Dec 1, 1999
Study Completion Date
:
Sep 1, 2002
Outcome Measures
Primary Outcome Measures
- To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia. []
Secondary Outcome Measures
- Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and 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 will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle []
- Assess the safety of multiple intravenous doses of rhTPO []
- Determine the occurrence and clinical implications of any anti-rhTPO antibodies []
- Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness []
- Evaluate the impact of rhTPO administration on patient quality of life []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support
Exclusion Criteria:
- Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Berkeley | California | United States | 94704 |
| 2 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 3 | Pfizer Investigational Site | Los Angeles | California | United States | 90033-0804 |
| 4 | Pfizer Investigational Site | Los Angeles | California | United States | 90067 |
| 5 | Pfizer Investigational Site | New Orleans | Louisiana | United States | 70115 |
| 6 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 7 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1114 |
| 8 | Pfizer Investigational Site | Buenos Aires | Capital Federal | Argentina | 1406 |
| 9 | Pfizer Investigational Site | Mexico City | DF | Mexico | 02990 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00037791
Other Study ID Numbers:
- 98-OTPO-005
First Posted:
May 22, 2002
Last Update Posted:
Nov 9, 2006
Last Verified:
Sep 1, 2006