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Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InterMune
ClinicalTrials.gov Identifier:
NCT01366209
First received: June 2, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Pirfenidone
Drug: Placebo
Phase 3

Study Type: 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
Official Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

Resource links provided by NLM:


Further study details as provided by InterMune:

Primary Outcome Measures:
  • Change in percent predicted forced vital capacity (%FVC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 555
Study Start Date: June 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Arm Drug: Pirfenidone
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Comparator: Placebo Arm Drug: Placebo
Placebo equivalent given as 3 divided doses 3 times per day.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Select Inclusion Criteria:

  1. Diagnosis of definite or probable Idiopathic Pulmonary Fibrosis (IPF) per the ATS 2011 Guidelines up to 48 months before randomization
  2. Age 40 to 80 at randomization
  3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
  4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

Select Exclusion Criteria:

  1. Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
  2. Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
  3. Known explanation for interstitial lung disease
  4. History of asthma or chronic obstructive pulmonary disease
  5. Active infection
  6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
  7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366209

Locations
United States, California
InterMune Inc.
Brisbane, California, United States, 94005
Sponsors and Collaborators
InterMune
Investigators
Study Chair: For additional information, call InterMune Medical Information Telephone: 1-888-486-6411 InterMune
  More Information

No publications provided by InterMune

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InterMune
ClinicalTrials.gov Identifier: NCT01366209     History of Changes
Other Study ID Numbers: PIPF-016
Study First Received: June 2, 2011
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
Pirfenidone
ASCEND
IPF
FVC

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Pirfenidone
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014