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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. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-16007958 |
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Date of registration:
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2016-02-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositis
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Scientific title:
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An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositis |
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Date of first enrolment:
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2014-06-01 |
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Target sample size:
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Rsearch group:30;Control group:30; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=13454 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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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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Guo Li
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Address:
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2000 Jiangyue Road, Shanghai
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Telephone:
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+86 15618965227 |
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Email:
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guoliyixueyuan@163.com |
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Affiliation:
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Renji Hospital, Shanghai Jiaotong University School of Medicine |
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Name:
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Ye Shuang
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Address:
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2000 Jiangyue Road, Shanghai
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Telephone:
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+86 021-34506393 |
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Email:
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yeshuang_2000@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. aged >16 years;
2. the patient or family members signed the informed consent voluntarily;
3. agreed to adopt effective contraceptive measures during the study period (child-bearing women);
4. disease rapid progression within six months (according to the 2011 guideline for IPF: progressive dyspnea, HRCT shows deteriorate of pulmonary fibrosis, FVC decreases by 10% compared with baseline, DLCO decreases by 15% compared with baseline).
Exclusion criteria: 1. merge with other connective tissue diseases;
2. merge with tumor;
3. patients with severe liver damage (liver enzyme > 2 times upper limit of normal;
4. patients are reluctant to sign the informed consent.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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clinically amyopathic dermatomyositis
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Intervention(s)
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Rsearch group: glucocorticoids+immunosuppressant+pirfenidone;Control group: glucocorticoids+immunosuppressant;
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Primary Outcome(s)
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survival of 6 months;survival of 12 months;
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Secondary Outcome(s)
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HRCT score of lung;FVC;
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Source(s) of Monetary Support
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self-collected funds
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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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