Clinical trial NCT01759511: Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic
Pulmonary
Fibrosis
IPF
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-01-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of 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.


Eligibility criteria: Key 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

Key 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 simtuzumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Overall Safety Profile of Simtuzumab
timeFrame: 30 days post last study treatment (up to 165 weeks)
Secondary outcomes:
measure: Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
timeFrame: Weeks 72 and 144
measure: Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
timeFrame: Weeks 72 and 144
measure: All-cause Mortality
timeFrame: Up to 165 weeks
measure: Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
timeFrame: Weeks 72 and 120
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: Los Angeles
country: United States
facility: University of California
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: