|
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:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02136992 |
|
Date of registration:
|
11/05/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
IPF |
|
Scientific title:
|
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis |
|
Date of first enrolment:
|
December 2011 |
|
Target sample size:
|
160 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02136992 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Contacts
|
|
Name:
|
Huiping Li |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Shanghai Pulmonary Hospital , Tongji University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Written informed consent signed;
2. Age =75 years;
3. Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011
guidance );
4. Resting state PaO2=50mg, FVC%=45% normal predicted value and DLCO=30% normal
predicted value.
Exclusion Criteria:
1. Allergic to pirfenidone;
2. Patients with serious Significant pulmonary infection need anti-infection treatment;
3. Patients who has taken interferon, penicillamine or other agents for the treatment of
IPF;
4. Patients who has taken prednisone(=50mg) or other glucocorticoid in the past 1 month;
5. Patients who has taken immunosuppressants in the past 1 month;
6. Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3
months;
7. Patients with malignant tumor in the past 5 years;
8. Participated in other clinical trials in the past 3 months;
9. Patients with serious heart disease(NYHA class ?-?), liver disease(ALT or AST 2 times
above the upper level of normal value range), kidney disease(Cr above the upper level
of normal value range);
10. Pregnant or lactating women;
11. The investigator assessed as inappropriate to participate in this clinical trial.
Age minimum:
N/A
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Pulmonary Fibrosis
|
|
Intervention(s)
|
|
Drug: Pirfenidone
|
|
Drug: placebo
|
|
Primary Outcome(s)
|
|
Changes in forced vital capacity (FVC)
[Time Frame: 48 weeks]
|
|
Secondary Outcome(s)
|
|
changes in lung function (including Forced expiratory volume in one second (FEV1) and The differences of diffusing capacity of the lung for carbon monoxide (DLco) )
[Time Frame: 48week]
|
|
Changes in 6 minute walk distance (6MWD)
[Time Frame: 48 weeks]
|
|
Life quality: assessed by St. George respiratory questionnaire (SGRQ).
[Time Frame: 48 weeks]
|
|
Dyspnea score according by Modified Medical Research Center(MMRC)
[Time Frame: 48 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|