|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-IOR-16008738 |
|
Date of registration:
|
2016-06-28 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemia
|
|
Scientific title:
|
A single center, randomized, controlled, opened label study for evaluating Cyclosporin alone or combined with Stanozolol in the treatment of aplastic anemia |
|
Date of first enrolment:
|
2016-08-01 |
|
Target sample size:
|
A:100;B:100; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=13755 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Yingmei Li
|
|
Address:
|
1 East Jianshe Road, Zhengzhou, Henan, China
|
|
Telephone:
|
+86 13674999228 |
|
Email:
|
yingmeibt@163.com |
|
Affiliation:
|
The First Affiliated Hospital of Zhengzhou University |
|
|
Name:
|
Yingmei Li
|
|
Address:
|
1 East Jianshe Road, Zhengzhou, Henan, China
|
|
Telephone:
|
+86 13674999228 |
|
Email:
|
yingmeibt@163.com |
|
Affiliation:
|
The First Affiliated Hospital of Zhengzhou University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Patients with Non-severe aplastic anemia do not rely on transfusion;
2. Patients with Severe aplastic anemia or Non-severe aplastic anemia relying on transfusion have no condition treated with HSCT or ATG;
3. Aged between 18 to 65 years old;
4. Have not history of cyclosporin, androgens, HSCT or other immunosuppressants treatment;
5. Sign the informed consent document.
Exclusion criteria: 1. With severe organ dysfunction or diseas, such as heart, lung, kidney,pancreas;
2. WIth active hepatitis, syphilis and HIV;
3. Any cause of abormal liver function, grater than twice the normal in ALT/AST or TBIL;
4. ECOG score >2;
5. Pregnant patients;
6. Congenital hematopoietic failure;
7. Uncontrolled infection.
Age minimum:
18
Age maximum:
65
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
aplastic anemia
|
|
Intervention(s)
|
|
A:Cyclosporin;B:Cyclosporin and Stanozolol;
|
|
Primary Outcome(s)
|
|
blood routine;bone marrow exmination;blood biochemistry;Cyclosporine blood concentration;
|
|
Source(s) of Monetary Support
|
|
The First Affiliated Hospital of Zhengzhou University Dr.Scientific Research Foundation
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|