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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InterMune
ClinicalTrials.gov Identifier:
NCT01366209
First received: June 2, 2011
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 500
Study Start Date: June 2011
Estimated 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
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

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 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
Pirfenidone
ASCEND
IPF
FVC

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

ClinicalTrials.gov processed this record on June 18, 2013