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A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Idiopathic Pulmonary Fibrosis

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Trial Information

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for the Safety and Efficacy of Pirfenidone in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)


Inclusion Criteria:



1. Written informed consent signed;

2. 18-75 years of age;

3. Clinically or multidisciplinarily 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. Dyspnea symptoms relieved in the past 6 months;

3. Patients in acute exacerbation phase;

4. Diabetic patients whose fasting venous glucose >11.1 mmol/L;

5. Patients with malignant tumor and hemorrhagic diseases;

6. Patients with serious underlying pulmonary disease;

7. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), 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);

8. Patients who has taken Acetylcysteine in the past 3 months;

9. Patients who has taken Prednisone>15mg/day(or other equivalent amount of
glucocorticoid) and/or Immunosuppresants in the past 3 months;

10. Patients who has taken interferon, penicillamine, colchine or other agents for the
treatment of IPF;

11. Pregnant or lactating women;

12. Participated in other clinical trials in the past 1 month;

13. The investigator assessed as inappropriate to participate in this clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Changes in forced vital capacity (FVC)

Outcome Description:

Changes in FVC from 48 weeks to baseline

Outcome Time Frame:

48 weeks

Safety Issue:

No

Principal Investigator

Xu Zuojun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking Union Medical College Hospital

Authority:

China: Food and Drug Administration

Study ID:

KAWIN-001

NCT ID:

NCT01504334

Start Date:

January 2012

Completion Date:

March 2013

Related Keywords:

  • Idiopathic Pulmonary Fibrosis
  • Fibrosis
  • Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis

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