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OpenTrials
Completed

NCT Number: NCT00037791

Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

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.

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Key information

Conditions

Neoplasms Blood Platelet Disorders Blood Protein Disorders Cardiovascular Diseases Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Malignant Lymphoproliferative Disorders Multiple Myeloma Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Thrombocytopenia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Buenos Aires, Buenos Aires F.D., Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(PN-152,243)/PN-196,444

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis

  3. Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia

  4. Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle

  5. Assess the safety of multiple intravenous doses of rhTPO

  6. Determine the occurrence and clinical implications of any anti-rhTPO antibodies

  7. Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness

  8. Evaluate the impact of rhTPO administration on patient quality of life

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
1999
Study completion
2002
First posted
May 22, 2002
Registry last updated
Nov 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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