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Long-Term Safety Study of GS-6624 to Treat Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01759511
First received: November 15, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to determine if the long-term effects of GS-6624 are safe and tolerable for people with Idiopathic Pulmonary Fibrosis (IPF).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: simtuzumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Number of subject with Adverse Events as a measure for safety and tolerability [ Time Frame: 3 years from the first subject enrolled ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in Forced Vital Capacity [ Time Frame: 3 years from first subject enrolled ] [ Designated as safety issue: Yes ]
  • Change in Diffusing Lung Capacity for Carbon Monoxide [ Time Frame: Over the duration of the study ] [ Designated as safety issue: No ]
    A measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.


Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Gilead Sciences -6624
Open label, 200 milligrams IV infusion of simtuzumab, every 14 days, over 30 minutes
 Drug: simtuzumab
200 milligrams IV infusion of simtuzumab, every 14 days
Other Name: GS-6624

Detailed Description:

The main goal of this study is to accumulate long term safety and tolerability data from subjects treated with GS-6624 for one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in Phase 1 Gilead clinical trial
  • Diagnosis of Idiopathic Pulmonary Fibrosis
  • Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
  • Females must discontinue nursing
  • Comply with study requirements
  • Have adequate organ function

Exclusion Criteria:

  • History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
  • Pregnant or lactating
  • Clinically significant heart, hepatic or renal disease
  • History of cancer within 5 years of screening
  • Infection that is not controlled despite antibiotics or other treatment
  • History of bleeding diathesis within the last 6 months of Day 1
  • Known history of Human Immunodeficiency Virus, hepatitis B or C
  • Concern's for subjects compliance
  • Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
  • Placed on a lung transplant list
  • Previous participation in an Idiopathic Pulmonary Fibrosis clinical trial other than for Gilead Sciences -6624
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759511

Locations
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States, 85012
United States, California
University of California
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Jason Chien, MD, MS Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01759511     History of Changes
Other Study ID Numbers: GS-US-322-0206
Study First Received: November 15, 2012
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Idiopathic
Pulmonary
Fibrosis
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 16, 2013