Safety and Efficacy Study of Pirfenidone to Treat Idiopathic Pulmonary Fibrosis(IPF)

NCT01504334 | Unknown Phase 2 DMC

• 1 other identifier: KAWIN-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of lung disease characterized by fibrosis of the supporting framework (interstitium) of the lungs. By definition, the term is used only when the cause of the pulmonary fibrosis is unknown ("idiopathic"). Microscopically, lung tissue from patients shows a characteristic set of histologic/pathologic features known as usual interstitial pneumonia (UIP). UIP is therefore the pathologic counterpart of IPF.Idiopathic pulmonary fibrosis is characterized by radiographically evident interstitial infiltrates predominantly affecting the lung bases and by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides a new focus for basic and clinical research that will improve insight into the pathogenesis of this disorder and stimulate the development of novel therapies. Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro systems and animal models of pulmonary fibrosis, although its precise mechanism of action remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokines such as transforming growth factor-β. It is also shown to slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor and platelet-derived growth factor. Pirfenidone has not been widely approved for clinical use in China, in this study, safety and efficacy were evaluated to see if pirfenidone has a significant advantage over placebo in terms of improving lung function and life quality etc. (see primary and secondary criteria) or slows down the deterioration of lung function in Chinese subjects diagnosed with IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Changes in forced vital capacity (FVC)

  Changes in FVC from 48 weeks to baseline

  48 weeks

Secondary Outcomes (7)

• Changes in lung function (including arterial blood gas analysis)

  48 weeks

• Acute Exacerbation during the whole treatment procedure（frequency and severity）

  48 weeks

• Progression-free time

  48 weeks

• 6 Minute Walk Test (6MWT )： Changes in 6 minute walk distance (6MWD) and SpO2 from 48 weeks to baseline

  48 weeks

• Borg RPE scale rating improvement rate during the whole study period

  48 weeks

Study Arms (2)

Pirfenidone(200mg)

EXPERIMENTAL

Pirfenidone（200mg）tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week.

Drug: Pirfenidone

Placebo (without active ingredient)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pirfenidone DRUG

Pirfenidone（200mg）tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week.

Pirfenidone(200mg)

Placebo DRUG

Placebo（without active ingredient） tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week for both groups.

Placebo (without active ingredient)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed;
• years of age;
• Clinically or multidisciplinarily diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
• Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.

You may not qualify if:

• Allergic to pirfenidone;
• Dyspnea symptoms relieved in the past 6 months;
• Patients in acute exacerbation phase;
• Diabetic patients whose fasting venous glucose \>11.1 mmol/L;
• Patients with malignant tumor and hemorrhagic diseases;
• Patients with serious underlying pulmonary disease;
• 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);
• Patients who has taken Acetylcysteine in the past 3 months;
• Patients who has taken Prednisone\>15mg/day(or other equivalent amount of glucocorticoid) and/or Immunosuppresants in the past 3 months;
• Patients who has taken interferon, penicillamine, colchine or other agents for the treatment of IPF;
• Pregnant or lactating women;
• Participated in other clinical trials in the past 1 month;
• The investigator assessed as inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Beijing Kawin Technology Share-Holding Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijng, 100032, China

RECRUITING

Related Publications (1)

• Huang H, Dai HP, Kang J, Chen BY, Sun TY, Xu ZJ. Double-Blind Randomized Trial of Pirfenidone in Chinese Idiopathic Pulmonary Fibrosis Patients. Medicine (Baltimore). 2015 Oct;94(42):e1600. doi: 10.1097/MD.0000000000001600.

  PMID: 26496265 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xu Zuojun, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Zuojun, MD

CONTACT

+86-10-65295039; xuzj@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 5, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

CN (1)