CClinicalTrials.gg
CompletedNCT00037791Updated Nov 9, 2006

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

A Phase 3 interventional study of (PN-152,243)/PN-196,444 in Neoplasms, Thrombocytopenia and Multiple Myeloma, sponsored by Pfizer. Completed at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-09.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Neoplasms
  • Thrombocytopenia
  • Multiple Myeloma
  • Lymphoma, Malignant
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 180 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
180 participants

Interventions

  • Drug(PN-152,243)/PN-196,444
06

What researchers measure

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

07

Study locations

9 sites
  • Pfizer Investigational Site
    Berkeley, California 94704, United States
  • Pfizer Investigational Site
    La Jolla, California 92037, United States
  • Pfizer Investigational Site
    Los Angeles, California 90033-0804, United States
  • Pfizer Investigational Site
    Los Angeles, California 90067, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana 70115, United States
  • Pfizer Investigational Site
    Houston, Texas 77030, United States
  • Pfizer Investigational Site
    Buenos Aires, Capital Federal 1114, Argentina
  • Pfizer Investigational Site
    Buenos Aires, Capital Federal 1406, Argentina
  • Pfizer Investigational Site
    Mexico City, DF 02990, Mexico
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00037791
Lead sponsor
Pfizer
First posted
May 22, 2002
Start date
Dec 1999
Completion
Sep 2002
Last update
Nov 9, 2006

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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