Chemotherapy-induced ThrombocytopeniaNCT03049774
A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor
An observational study of Chemotherapy-induced Thrombocytopenia, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Liu, 13910216310, 13910216310@163.com
Yuankai Shi
About this study
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
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 56 days
Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L
For treatment
Measured: 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
For prevention
Measured: 56 days
the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle
For prevention
Measured: 56 days
The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle
For prevention
Measured: 56 days
the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L
For treatment
Measured: 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
Measured: 28 days after the administration of Baijieyi
The number of platelet transfusions
For treatment
Measured: 28 days after the administration of Baijieyi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start28 Feb 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049774
- Sponsor's protocol ID
- EY201608
- Status last verified
- Aug 2016
- First submitted
- 23 Jan 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03049774
- Acronym / sponsor ID
- EY201608
- Conditions
- Chemotherapy-induced Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 56 days
For prevention
Days that platelet count firstly rebound to 75×10^9/L, 100×10^9/L
Time frame: 28 days after the administration of Baijieyi
For treatment
6 secondary outcomes
the maximum and minimum platelet count at the chemotherapy cycle and the last chemotherapy cycle
Time frame: 56 days
the lasting days of platelet count below 50×10^9/L at the chemotherapy cycle and the last chemotherapy cycle
Time frame: 56 days
The number of platelet transfusions at the chemotherapy cycle and the last chemotherapy cycle
Time frame: 56 days
the percentage of patients whose platelet count firstly recovered above 75×10^9/L and 100×10^9/L
Time frame: 28 days after the administration of Baijieyi
the maximum and minimum platelet count, the lasting days of platelet count below 50×10^9/L
Time frame: 28 days after the administration of Baijieyi
The number of platelet transfusions
Time frame: 28 days after the administration of Baijieyi
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Thrombocytopenia, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.