A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone

• ClinicalTrials.gov Identifier: NCT00052039
• Recruitment Status: Terminated
• First Posted: January 22, 2003
• Last Update Posted: November 6, 2007
• Sponsor: InterMune
• Information provided by: InterMune

Tracking Information

• First Submitted Date: January 21, 2003
• First Posted Date: January 22, 2003
• Last Update Posted Date: November 6, 2007
• Study Start Date: April 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 2, 2007): This study was terminated prior to enrollment. [ Time Frame: This study was terminated prior to enrollment. ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone
• Official Title: A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone
• Brief Summary: Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Lung Disease
• Pulmonary Fibrosis

Intervention

• Drug: interferon-gamma 1b
  This study was terminated prior to enrollment.
• Drug: azathioprine
  This study was terminated prior to enrollment.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 2, 2007): 0
• Original Enrollment (submitted: June 23, 2005): 210
• Actual Study Completion Date: June 2002
• Primary Completion Date: Not Provided
• Eligibility Criteria: Not Provided

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00052039
• Other Study ID Numbers: GIPF-003
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: InterMune
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Steven Porter, MD; InterMune

• PRS Account: InterMune
• Verification Date: November 2007