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

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-induced Thrombocytopenia

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Peng Liu; Phone Number: 13910216310; Email: 13910216310@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle	For prevention	56 days
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
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
The number of platelet transfusions	For treatment	28 days after the administration of Baijieyi

Other Outcome Measures

Outcome Measure	Time Frame
adverse events, serious adverse events, laboratory tests, ECG	28 days after the administration of Baijieyi

Collaborators and Investigators

• Sponsor: Angde Biotech Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 28, 2017
• Primary Completion (ANTICIPATED): August 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (ACTUAL): February 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Neoplasms; Thrombocytopenia
• Other Study ID Numbers: EY201608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No