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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-OOC-15005862
Date of registration: 2015-01-19
Prospective Registration: No
Primary sponsor: Shanghai Pulmonary Hospital
Public title: The clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis.
Scientific title: An Open-label, parallel, randomized controlled clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis.
Date of first enrolment: 2015-01-01
Target sample size: treatment group:50;control group:50;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=10288
Study type:  Observational study
Study design:  Case series  
Phase:  Other
Countries of recruitment
China
Contacts
Name: Huiping Li   
Address:  507 Zheng Min Road, Shanghai
Telephone: +86 13817389991
Email: liw2013@126.com
Affiliation: 
Name: Huiping Li   
Address:  507 Zheng Min Road, Shanghai
Telephone: +86 13817389991
Email: liw2013@126.com
Affiliation:  Shanghai Pulmonary Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Idiopathic pulmonary fibrosis (IPF) patients are diagnosed according to the 2011 ATS / ERS / JRS / ALAT;
2. Male or female without pregnancy,aged during 50 to 80 years old;
3. Have good compliance, willing to exercise in accordance with the program and follow-up with the schedule;
4. Patients were fully informed of the purpose, method and possible discomfort of the test, agree and signed in consent.

Exclusion criteria: 1. Having serious diseases in other system and organ dysfunction;
2. Having malignant tumor;
3. Participating in other clinical trials within three months;
4. Patients with abnormal renal function: Creatinine value > 1.5 times of the upper limit of normal value;
5. Patients with splenomegaly;
6. Patients With diseases of the blood system;
7. Pregnancy, breast-feeding women, planning to pregnant and those who can not take effective contraceptive measures;
8. There is any unsuitable situation for those selected.


Age minimum: 50
Age maximum: 80
Gender: Both
Health Condition(s) or Problem(s) studied
idiopathic pulmonary fibrosis
Intervention(s)
treatment group:subcutaneous injection of Granulocyte colony stimulating factor termly;control group:no processing;
Primary Outcome(s)
the score of The St George's;times of hospitalization due to the aggravation;
Secondary Outcome(s)
lung function (forced vital capacity, carbon monoxide diffusion capacity, the ratio of first second forced vital capacity to forced vital capacity);The changes of high resolution computed tomography;arterial blood gases(Partial pressure of oxygen partial pressure, carbon dioxide, arterial blood oxygen saturation);indicators related to pulmonary fibrosis;End of treatment of pulmonary fibrosis related events (such as the death toll);results of six-minutes walking test;
Secondary ID(s)
Source(s) of Monetary Support
the researcher conduct, no funding
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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