A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor

• Conditions: Chemotherapy-induced Thrombocytopenia

• Registration Number: NCT03049774
• Lead Sponsor: Angde Biotech Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10
• Study Start: 2017-02-28
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L	28 days after the administration of Baijieyi	For treatment
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	56 days	For prevention

Secondary Outcome Measures

Name	Time	Method
the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L	28 days after the administration of Baijieyi	For treatment
The number of platelet transfusions	28 days after the administration of Baijieyi	For treatment
the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle	56 days	For prevention
the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle	56 days	For prevention
The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle	56 days	For prevention
the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L	28 days after the administration of Baijieyi	For treatment

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China