Clinical trial · Observational
A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
A Retrospective Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
NCT03049774CI-TRIAL-00025902unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this retrospective study is to review and describe the safety and the efficacy of recombinant human interleukin-11 (I) i (Baijieyi), using information already recorded in 20 medical records, The time periods include May 8th of 2008 to december 31st of 2016.
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 |
|---|---|---|---|
| Chemotherapy-induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L, respectively, from the first time below 75×10^9/L at the chemotherapy cycle and the last chemotherapy cycle
- timeFrame
- 56 days
- description
- For prevention
- measure
- Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L
- timeFrame
- 28 days after the administration of Baijieyi
- description
- For treatment
Secondary outcomes (6)
- measure
- the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle
- timeFrame
- 56 days
- description
- For prevention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. prescriptions explicitly given to the injection of Baijieyi; 2. confirmed by histopathological or cytological examination of malignant tumors and chemotherapy; 3. treatment: platelet count had reached below 75×10\^9/L after the treatment of chemotherapy and before using Baijieyi; prevention: patients with chemotherapy at the beginning of the preventive administration of BaiJieyi, and chemotherapy is same with previous cycle; 4. male or female, aged 18-85 years; 5. The main research information required is complete. Exclusion Criteria: 1. using other platelets of chemicals or biological products in the in the chemotherapy cycle used Baijieyi; 2. using drugs which can cause thrombocytopenia in the in the chemotherapy cycle used Baijieyi; 3. bone marrow dysfunction or bone marrow involvement; 4. There are other causes of thrombocytopenia, such as aplastic anemia, acute leukemia, radiation sickness, immune thrombocytopenic purpura, and hypersplenism, in the course of the use of Baijieyi.
References
Publications (0)
Data not yet available
No reference posted for this study.