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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma, Malignant

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

98-OTPO-005

NCT ID:

NCT00037791

Start Date:

December 1999

Completion Date:

September 2002

Related Keywords:

  • Neoplasms
  • Thrombocytopenia
  • Multiple Myeloma
  • Lymphoma, Malignant
  • Neoplasms
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Thrombocytopenia

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteShreveport, Louisiana  71103