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

Chemotherapy-induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03049774
• Other study ID #: EY201608
• Status: Not yet recruiting
• Phase: N/A
• First received: January 23, 2017
• Last updated: February 8, 2017
• Start date: February 28, 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Angde Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Neoplasms
• Thrombocytopenia

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Angde Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events, serious adverse events, laboratory tests, ECG		28 days after the administration of Baijieyi
Primary	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	For prevention	56 days
Primary	Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L	For treatment	28 days after the administration of Baijieyi
Secondary	the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
Secondary	the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
Secondary	The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
Secondary	the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L	For treatment	28 days after the administration of Baijieyi
Secondary	the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L	For treatment	28 days after the administration of Baijieyi
Secondary	The number of platelet transfusions	For treatment	28 days after the administration of Baijieyi