Clinical trial · Interventional
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PN-152,243)/PN-196,444 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
Secondary outcomes (10)
- measure
- Identify the effect of rhTPO on the number of platelet transfusions.
- measure
- Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.
- measure
- Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.
- measure
- Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
- measure
- Assess the safety of multiple IV doses of rhTPO.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy Exclusion Criteria: * Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
References
Publications (0)
Data not yet available