Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

NCT02136992 | Completed Phase 2 DMC

• 1 other identifier: SPH01312
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Changes in forced vital capacity (FVC)

  to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks

  48 weeks

Secondary Outcomes (4)

• 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) )

  48week

• Changes in 6 minute walk distance (6MWD)

  48 weeks

• Life quality: assessed by St. George respiratory questionnaire (SGRQ).

  48 weeks

• Dyspnea score according by Modified Medical Research Center(MMRC)

  48 weeks

Study Arms (2)

Placebo (without active ingredient)

PLACEBO COMPARATOR

placebo will be taken two tablets 3 times a day during the whole study process.

Drug: Pirfenidone; Drug: placebo

Pirfenidone（200mg）

EXPERIMENTAL

Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.

Drug: Pirfenidone; Drug: placebo

Interventions

Pirfenidone DRUG

Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.

Pirfenidone（200mg）; Placebo (without active ingredient)

placebo DRUG

placebo will be taken two tablets 3 times a day during the whole study process

Pirfenidone（200mg）; Placebo (without active ingredient)

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent signed;
• Age ≤75 years;
• Clinically or multidisciplinary 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;
• Patients with serious Significant pulmonary infection need anti-infection treatment;
• Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
• Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
• Patients who has taken immunosuppressants in the past 1 month;
• Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
• Patients with malignant tumor in the past 5 years;
• Participated in other clinical trials in the past 3 months;
• 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);
• Pregnant or lactating women;
• The investigator assessed as inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Nanjing Chia-tai Tianqing Pharmaceutical: collaborator

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

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

Study Officials

• Huiping Li

  Shanghai Pulmonary Hospital , Tongji University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Huiping Li

Study Record Dates

• First Submitted: May 11, 2014
• First Posted: May 13, 2014
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05