Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00080223
• Date of registration: 24/03/2004
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
• Scientific title: An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
• Date of first enrolment: August 31, 2003
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00080223
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

General Inclusion Criteria:

- Able to understand and sign an informed consent form

- Understand the importance of adherence to study treatment and the study protocol,
including concomitant medication restrictions, throughout the study period

- Patients must be willing to travel to an approved regional center for all
study-related visits

Roll-Over Criteria:

- Entry into study through rollover has been completed

Criteria for Early Access Program patients:

- Clinical symptoms consistent with IPF =3 months duration

- Age 40 - 85, inclusive

- At the time of registration with National Organization for Rare Disorders (NORD),
patients with IPF must have a percent predicted forced vital capacity (FVC) of =50%,
and percent predicted carbon monoxide diffusing capacity (DLCO) of =35%

- At the time of enrollment in PIPF-002, (screening/baseline visit) percent predicted
FVC must be =45%, and percent predicted DLCO must be =30%

- High-resolution computed tomographic scan (HRCT) showing definite IPF. For patients
with surgical lung biopsy showing definite or probable usual interstitial pneumonia
(UIP), the HRCT criterion of probable IPF is sufficient

- For patients aged <50 years: open or video-assisted thoracoscopic (VATS) lung biopsy
showing definite or probable UIP. In addition, no features supporting an alternative
diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed

- For patients aged =50 years: at least one of the following diagnostic findings as well
as the absence of any features on specimens resulting from any of these procedures
that support an alternative diagnosis: 1) Open or VATS lung biopsy showing definite or
probable UIP; 2) Transbronchial biopsy showing no features to support an alternative
diagnosis; 3) Bronchoalveolar lavage (BAL) showing no features to support an
alternative diagnosis



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis

Intervention(s)

Drug: Pirfenidone

Primary Outcome(s)

Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE [Time Frame: Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)]

Secondary Outcome(s)

Resting Oxygen Saturation by Pulse Oximetry (SpO2) [Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480]

Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco) [Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480]

Percent Predicted Forced Vital Capacity (FVC) [Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480]

Overall Survival [Time Frame: First dosing of study treatment until death (up to 604 weeks)]

Secondary ID(s)

GA29989

PIPF-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00080223