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Trial record 90 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

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

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.
ClinicalTrials.gov Identifier: NCT01759511
Recruitment Status : Terminated (The Study was terminated due to lack of efficacy.)
First Posted : January 3, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Intervention Drug: Simtuzumab
Enrollment 34
Recruitment Details Participants were enrolled at 6 study sites in the United States. The first participant was screened on 18 October 2012. The last study visit occurred on 19 February 2016.
Pre-assignment Details 37 participants were screened.
Arm/Group Title Simtuzumab
Hide Arm/Group Description 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Period Title: Overall Study
Started 34
Completed 0
Not Completed 34
Reason Not Completed
Adverse Event             4
Death             2
Lack of Efficacy             2
Physician Decision             1
Progressive Disease             5
Protocol-Specified Criteria for Withdraw             4
Study Terminated by Sponsor             13
Withdrawal by Subject             3
Arm/Group Title Simtuzumab
Hide Arm/Group Description 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
Safety Analysis Set: all participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
67.9  (7.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
9
  26.5%
Male
25
  73.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 34 participants
34
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Hispanic or Latino
1
   2.9%
Not Hispanic or Latino
33
  97.1%
Forced vital capacity (FVC) Percent Predicted  
Mean (Standard Deviation)
Unit of measure:  FVC % predicted
Number Analyzed 34 participants
69.9  (14.18)
FVC % Predicted Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Mild
12
  35.3%
Moderate
16
  47.1%
Severe
6
  17.6%
Forced expirator volume in the first second of expiration (FEV1)/FVC Ratio  
Mean (Standard Deviation)
Unit of measure:  Liter
Number Analyzed 34 participants
0.8  (0.23)
Hemoglobin-Corrected Carbon dioxide diffusing capacity (DLCO) Predicted  
Mean (Standard Deviation)
Unit of measure:  DLCO % predicted
Number Analyzed 34 participants
12.2  (4.22)
1.Primary Outcome
Title Overall Safety Profile of Simtuzumab
Hide Description The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.
Time Frame 30 days post last study treatment (up to 165 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Simtuzumab
Hide Arm/Group Description:
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Events (AEs) 97.1
Grade 3 or 4 AEs 47.1
Serious Adverse Events 35.3
SAEs Related to simtuzumab 5.9
AEs leading to discontinuation of simtuzumab 29.4
2.Secondary Outcome
Title Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
Hide Description
  • FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
  • Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.
Time Frame Weeks 72 and 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Simtuzumab
Hide Arm/Group Description:
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Participants Analyzed 34
Least Squares Mean (Standard Error)
Unit of Measure: percent change in FVC % predicted
Week 72 Number Analyzed 19 participants
-8.05  (1.829)
Week 144 Number Analyzed 13 participants
-12.04  (2.086)
3.Secondary Outcome
Title Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
Hide Description
  • DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
  • Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.
Time Frame Weeks 72 and 144
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Safety Analysis Set with available data were analyzed.
Arm/Group Title Simtuzumab
Hide Arm/Group Description:
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Participants Analyzed 34
Least Squares Mean (Standard Error)
Unit of Measure: percent change in DLCO % predicted
Week 72 Number Analyzed 19 participants
-7.41  (3.062)
Week 144 Number Analyzed 13 participants
-22.80  (3.475)
4.Secondary Outcome
Title All-cause Mortality
Hide Description All-cause mortality was assessed as a number of participants who died from any cause.
Time Frame Up to 165 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Simtuzumab
Hide Arm/Group Description:
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
3
   8.8%
5.Secondary Outcome
Title Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
Hide Description [Not Specified]
Time Frame Weeks 72 and 120
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis set with available data were analyzed.
Arm/Group Title Simtuzumab
Hide Arm/Group Description:
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Overall Number of Participants Analyzed 34
Least Squares Mean (Standard Error)
Unit of Measure: percent change in sLOXL2
Week 72 Number Analyzed 19 participants
5.93  (5.937)
Week 120 Number Analyzed 16 participants
-0.69  (6.032)
Time Frame 30 days post last study treatment (up to 165 weeks)
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Simtuzumab
Hide Arm/Group Description 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
All-Cause Mortality
Simtuzumab
Affected / at Risk (%)
Total   3/34 (8.82%) 
Show Serious Adverse Events Hide Serious Adverse Events
Simtuzumab
Affected / at Risk (%)
Total   12/34 (35.29%) 
Blood and lymphatic system disorders   
Leukocytosis  1  1/34 (2.94%) 
Cardiac disorders   
Arteriosclerosis coronary artery  1  1/34 (2.94%) 
Coronary artery disease  1  1/34 (2.94%) 
Coronary artery occlusion  1  1/34 (2.94%) 
Myocardial infarction  1  1/34 (2.94%) 
Gastrointestinal disorders   
Hiatus hernia  1  1/34 (2.94%) 
General disorders   
Chest pain  1  1/34 (2.94%) 
Infections and infestations   
Influenza  1  1/34 (2.94%) 
Pneumonia  1  3/34 (8.82%) 
Urinary tract infection  1  1/34 (2.94%) 
Musculoskeletal and connective tissue disorders   
Chondrocalcinosis pyrophosphate  1  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung adenocarcinoma  1  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  2/34 (5.88%) 
Dyspnoea  1  1/34 (2.94%) 
Idiopathic pulmonary fibrosis  1  1/34 (2.94%) 
Pneumothorax  1  1/34 (2.94%) 
Pulmonary fibrosis  1  1/34 (2.94%) 
Respiratory failure  1  1/34 (2.94%) 
Vascular disorders   
Aortic stenosis  1  1/34 (2.94%) 
Hypertension  1  1/34 (2.94%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simtuzumab
Affected / at Risk (%)
Total   33/34 (97.06%) 
Blood and lymphatic system disorders   
Anaemia  1  4/34 (11.76%) 
Cardiac disorders   
Tachycardia  1  2/34 (5.88%) 
Eye disorders   
Cataract  1  2/34 (5.88%) 
Dry eye  1  2/34 (5.88%) 
Gastrointestinal disorders   
Abdominal discomfort  1  2/34 (5.88%) 
Abdominal pain  1  2/34 (5.88%) 
Abdominal pain upper  1  2/34 (5.88%) 
Constipation  1  7/34 (20.59%) 
Diarrhoea  1  5/34 (14.71%) 
Flatulence  1  2/34 (5.88%) 
Nausea  1  4/34 (11.76%) 
General disorders   
Chest discomfort  1  2/34 (5.88%) 
Chest pain  1  2/34 (5.88%) 
Chills  1  2/34 (5.88%) 
Fatigue  1  10/34 (29.41%) 
Infusion site extravasation  1  2/34 (5.88%) 
Injection site bruising  1  2/34 (5.88%) 
Malaise  1  2/34 (5.88%) 
Oedema peripheral  1  8/34 (23.53%) 
Pyrexia  1  3/34 (8.82%) 
Infections and infestations   
Bronchitis  1  7/34 (20.59%) 
Gastroenteritis  1  2/34 (5.88%) 
Influenza  1  2/34 (5.88%) 
Nail infection  1  2/34 (5.88%) 
Nasopharyngitis  1  4/34 (11.76%) 
Pneumonia  1  2/34 (5.88%) 
Sinusitis  1  4/34 (11.76%) 
Upper respiratory tract infection  1  7/34 (20.59%) 
Urinary tract infection  1  3/34 (8.82%) 
Injury, poisoning and procedural complications   
Fall  1  2/34 (5.88%) 
Laceration  1  2/34 (5.88%) 
Procedural pain  1  4/34 (11.76%) 
Investigations   
Blood pressure increased  1  2/34 (5.88%) 
Gamma-glutamyltransferase increased  1  2/34 (5.88%) 
Occult blood positive  1  2/34 (5.88%) 
Weight decreased  1  2/34 (5.88%) 
Metabolism and nutrition disorders   
Decreased appetite  1  4/34 (11.76%) 
Hypokalaemia  1  2/34 (5.88%) 
Hyponatraemia  1  3/34 (8.82%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/34 (20.59%) 
Back pain  1  5/34 (14.71%) 
Muscle spasms  1  2/34 (5.88%) 
Musculoskeletal chest pain  1  3/34 (8.82%) 
Musculoskeletal pain  1  5/34 (14.71%) 
Pain in extremity  1  5/34 (14.71%) 
Nervous system disorders   
Dizziness  1  5/34 (14.71%) 
Headache  1  2/34 (5.88%) 
Syncope  1  2/34 (5.88%) 
Psychiatric disorders   
Anxiety  1  3/34 (8.82%) 
Depression  1  3/34 (8.82%) 
Mental status changes  1  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  18/34 (52.94%) 
Dyspnoea  1  7/34 (20.59%) 
Dyspnoea exertional  1  5/34 (14.71%) 
Epistaxis  1  2/34 (5.88%) 
Hypoxia  1  4/34 (11.76%) 
Idiopathic pulmonary fibrosis  1  3/34 (8.82%) 
Nasal congestion  1  3/34 (8.82%) 
Oropharyngeal pain  1  6/34 (17.65%) 
Pneumothorax  1  2/34 (5.88%) 
Productive cough  1  4/34 (11.76%) 
Pulmonary mass  1  2/34 (5.88%) 
Rhinitis allergic  1  2/34 (5.88%) 
Rhinorrhoea  1  2/34 (5.88%) 
Sinus congestion  1  3/34 (8.82%) 
Upper-airway cough syndrome  1  3/34 (8.82%) 
Skin and subcutaneous tissue disorders   
Precancerous skin lesion  1  2/34 (5.88%) 
Pruritus  1  2/34 (5.88%) 
Rash  1  5/34 (14.71%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01759511     History of Changes
Other Study ID Numbers: GS-US-322-0206
First Submitted: November 15, 2012
First Posted: January 3, 2013
Results First Submitted: February 17, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017