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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-18

Study Completion Date

2016-02-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simtuzumab

Participants will receive simtuzumab.

Group Type EXPERIMENTAL

Simtuzumab

Intervention Type DRUG

200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)

Interventions

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Simtuzumab

200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)

Intervention Type DRUG

Other Intervention Names

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GS-6624

Eligibility Criteria

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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 simtuzumab

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No