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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ATLAS  

Official title:

A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01759511
• Other study ID #: GS-US-322-0206
• Status: Terminated
• Phase: Phase 2
• First received: November 15, 2012
• Last updated: February 24, 2016
• Start date: October 2012
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with Idiopathic Pulmonary Fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Simtuzumab
Simtuzumab 125 mg/mL administered subcutaneously

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of California	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Arizona Pulmonary Specialists, Ltd.	Scottsdale	Arizona
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a measure for safety and tolerability		Baseline to Year 3	No
Secondary	Change in Forced Vital Capacity (FVC)	FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath.	Baseline to Year 3	No
Secondary	Change in Diffusing Lung Capacity for Carbon Monoxide (DLCO)	DLCO is a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.	Baseline to Year 3	No
Secondary	All-cause mortality	All-cause mortality will be assessed as a percentage of participants who die from any cause.	Baseline to Year 3	No
Secondary	Change in serum LOXL2 levels		Baseline to Year 3	No