Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Terminated
• Trial end date: 2016-02-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

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