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The Study was terminated due to lack of efficacy.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simtuzumab | Experimental | Participants will receive simtuzumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simtuzumab | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety Profile of Simtuzumab | 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. | 30 days post last study treatment (up to 165 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 |
| Weeks 72 and 144 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists, Ltd. | Scottsdale | Arizona | 85012 | United States | ||
| University of California |
37 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: all participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Safety Profile of Simtuzumab | 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. | Safety Analysis Set | Posted | Number | percentage of participants | 30 days post last study treatment (up to 165 weeks) |
|
|
30 days post last study treatment (up to 165 weeks)
Safety Analysis Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613471 | simtuzumab |
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|
| Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144 |
| Weeks 72 and 144 |
| All-cause Mortality | All-cause mortality was assessed as a number of participants who died from any cause. | Up to 165 weeks |
| Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 | Weeks 72 and 120 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Physician Decision |
|
| Progressive Disease |
|
| Protocol-Specified Criteria for Withdraw |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Forced vital capacity (FVC) Percent Predicted | Mean | Standard Deviation | FVC % predicted |
|
| FVC % Predicted Category | Count of Participants | Participants |
|
| Forced expirator volume in the first second of expiration (FEV1)/FVC Ratio | Mean | Standard Deviation | liter |
|
| Hemoglobin-Corrected Carbon dioxide diffusing capacity (DLCO) Predicted | Mean | Standard Deviation | DLCO % predicted |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 |
| Participants in Safety Analysis Set with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in FVC % predicted | Weeks 72 and 144 |
|
|
|
| Secondary | Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144 |
| Participants in Safety Analysis Set with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in DLCO % predicted | Weeks 72 and 144 |
|
|
|
| Secondary | All-cause Mortality | All-cause mortality was assessed as a number of participants who died from any cause. | Safety Analysis Set | Posted | Count of Participants | Participants | Up to 165 weeks |
|
|
|
| Secondary | Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 | Participants in the Safety Analysis set with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change in sLOXL2 | Weeks 72 and 120 |
|
|
|
| 3 |
| 34 |
| 12 |
| 34 |
| 33 |
| 34 |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nail infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Precancerous skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
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:
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
|