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

NCT03049774 | Unknown

• 1 other identifier: EY201608
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle

  56 days

• the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle

  56 days

• The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle

  56 days

• 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

• the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L

  28 days after the administration of Baijieyi

Other Outcomes (1)

• adverse events, serious adverse events, laboratory tests, ECG

  28 days after the administration of Baijieyi

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• prescriptions explicitly given to the injection of Baijieyi;
• confirmed by histopathological or cytological examination of malignant tumors and chemotherapy;
• 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;
• male or female, aged 18-85 years;
• The main research information required is complete.

You may not qualify if:

• using other platelets of chemicals or biological products in the in the chemotherapy cycle used Baijieyi;
• using drugs which can cause thrombocytopenia in the in the chemotherapy cycle used Baijieyi;
• bone marrow dysfunction or bone marrow involvement;
• 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.

Sponsors & Collaborators

• Angde Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 10, 2017
• Study Start: February 28, 2017
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 10, 2017

Record last verified: 2016-08

Locations

CN (1)