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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00037791
• Date of registration: 21/05/2002
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
• Scientific 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.
• Date of first enrolment: December 1999
• Target sample size: 180
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00037791
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Argentina, Mexico, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Neoplasms

Thrombocytopenia

Lymphoma, Malignant

Intervention(s)

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

Primary Outcome(s)

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(s)

Assess the safety of multiple intravenous doses of rhTPO

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

Evaluate the impact of rhTPO administration on patient quality of life

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

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

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

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

Secondary ID(s)

98-OTPO-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors