Main
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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:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-OOC-15005862 |
Date of registration:
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2015-01-19 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis.
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Scientific title:
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An Open-label, parallel, randomized controlled clinical study of the treatment by Granulocyte colony stimulating factor for idiopathic pulmonary fibrosis. |
Date of first enrolment:
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2015-01-01 |
Target sample size:
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treatment group:50;control group:50; |
Recruitment status: |
Recruiting |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10288 |
Study type:
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Observational study |
Study design:
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Case series
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Huiping Li
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Address:
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507 Zheng Min Road, Shanghai
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Telephone:
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+86 13817389991 |
Email:
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liw2013@126.com |
Affiliation:
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Name:
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Huiping Li
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Address:
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507 Zheng Min Road, Shanghai
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Telephone:
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+86 13817389991 |
Email:
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liw2013@126.com |
Affiliation:
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Shanghai Pulmonary Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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idiopathic pulmonary fibrosis
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Intervention(s)
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treatment group:subcutaneous injection of Granulocyte colony stimulating factor termly;control group:no processing;
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Primary Outcome(s)
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the score of The St George's;times of hospitalization due to the aggravation;
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Secondary Outcome(s)
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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;
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Source(s) of Monetary Support
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the researcher conduct, no funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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