We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362231
First Posted: May 30, 2011
Last Update Posted: July 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
April 12, 2011
May 30, 2011
July 9, 2015
December 2010
December 2012   (Final data collection date for primary outcome measure)
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 [ Time Frame: 113 days ]
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with IPF. [ Time Frame: 85 days ]

Primary Endpoints are:

  • Incidence of adverse events, clinically relevant changes in laboratory values, ECGs, and vital signs;
  • PK parameters including end of infusion drug concentration (Ceoi), area under the serum concentration over time (AUC), Clearance (Cl), and half-life (t½).

The safety and tolerability of each dose level will be assessed after patients in the cohort have been followed for at least 28 days after the first infusion of AB0024 or matching placebo.

Complete list of historical versions of study NCT01362231 on ClinicalTrials.gov Archive Site
- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ [ Time Frame: 113 Days ]

Secondary Endpoints:

  • Anti-GS-6624 antibody formation;
  • Change in FVC and DLCO;
  • Change in SGRQ score.
- To evaluate the formation of anti-AB0024 antibodies. - To assess the effects of AB0024 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of AB0024 treatment on SGRQ [ Time Frame: 85 Days ]

Secondary Endpoints:

  • Anti-AB0024 antibody formation;
  • Change in FVC and DLCO;
  • Change in SGRQ score.
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis

The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.

Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.

The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011.

In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Idiopathic Pulmonary Fibrosis
Drug: GS-6624
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Other Name: AB0024
  • Experimental: GS-6624 125mg
    Intervention: Drug: GS-6624
  • Experimental: Experimental: GS-6624 200mg
    Intervention: Drug: GS-6624
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Acceptable results on pulmonary function tests
  2. At rest oxygen saturation ≥90% on room air
  3. Adequate organ function

Exclusion Criteria:

  1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis
  2. Acceptable results on whole body plethysmography
  3. History of clinically significant hepatic or renal disease
  4. Poorly controlled or severe diabetes mellitus
  5. Use of systemic immunosuppressants within 28 days of GS-6624 infusion
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01362231
AB0024-201
Yes
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Zung Thai, MD Gilead Sciences
Gilead Sciences
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP