Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00287716
• Date of registration: 06/02/2006
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
• Scientific title: A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: July 14, 2006
• Target sample size: 435
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00287716
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Primary Inclusion criteria:

- diagnosis of idiopathic pulmonary fibrosis

- 40 to 80 years of age

- Forced Vital Capacity greater than or equal to 50% predicted value

- Carbon monoxide diffusing capacity greater than or equal to 35% predicted value

- either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal
to 90% predicted value

- no improvement in past year

- able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to
83% while on no more than 6 liters per minute (L/min) supplemental oxygen

Primary Exclusion criteria:

- unable to undergo pulmonary function testing

- evidence of significant obstructive lung disease or airway hyper-responsiveness

- in opinion of investigator patient is expected to need and be eligible for a lung
transplant within 72 weeks after randomization

- active infection

- liver disease

- cancer or other medical condition likely to result in death within 2 years

- diabetes

- pregnancy or lactation

- substance abuse

- personal or family history of long QT (Q wave,T wave) syndrome

- other IPF treatment

- unable to take study medication

- withdrawal from other IPF trials



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Placebo

Drug: Pirfenidone

Primary Outcome(s)

Absolute Change in Percent Predicted Forced Vital Capacity (FVC) [Time Frame: From baseline up to 72 weeks]

Secondary Outcome(s)

Change in Percent Predicted Hemoglobin (Hb)-Corrected Carbon Monoxide Diffusing Capacity (DLco) of the Lungs [Time Frame: Baseline to Week 72]

Change in Worst Oxygen Saturation by Pulse Oximetry (SpO2) Measurement Observed During the 6-Minute Walk Test [Time Frame: Baseline to Week 72]

Change in Dyspnea Score [Time Frame: Baseline to Week 72]

Change in Six-Minute Walk Test (6MWT)Distance [Time Frame: Baseline to Week 72]

Progression-free Survival (PFS) [Time Frame: Baseline to Week 72]

Worsening of Idiopathic Pulmonary Fibrosis (IPF) [Time Frame: Time to acute IPF exacerbation, IPF-related death, lung transplant or respiratory hospitalization, whichever comes first.]

Categorical Assessment of Absolute Change in Percent Predicted Forced Vital Capacity (FVC) [Time Frame: baseline up to 72 weeks]

Secondary ID(s)

Capacity 2

PIPF-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00287716