Clinical trial NCT03049774: A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
Official title: A Retrospective Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Thrombocytopenia
Lead sponsor: Angde Biotech Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 20 clinical centers: subjects.who have received one or more injections of Baijieyi for treatment or prevention of chemotherapy-induced thrombocytopenia

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
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
measure: Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L
timeFrame: 28 days after the administration of Baijieyi
Secondary outcomes:
measure: the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle
timeFrame: 56 days
measure: the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle
timeFrame: 56 days
measure: The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle
timeFrame: 56 days
measure: the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L
timeFrame: 28 days after the administration of Baijieyi
measure: the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L
timeFrame: 28 days after the administration of Baijieyi
measure: The number of platelet transfusions
timeFrame: 28 days after the administration of Baijieyi
Other outcomes:
measure: adverse events, serious adverse events, laboratory tests, ECG
timeFrame: 28 days after the administration of Baijieyi
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: