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Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)

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: NCT01672853
Recruitment Status : Completed
First Posted : August 27, 2012
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Primary Sclerosing Cholangitis (PSC)
Interventions Biological: Simtuzumab
Biological: Placebo
Enrollment 235
Recruitment Details Participants were enrolled at study sites in North America and Europe. The first participant was screened on 4 March 2013. The last study visit occurred on 24 August 2016.
Pre-assignment Details 298 participants were screened.
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description Simtuzumab (SIM) 75 mg subcutaneous injections weekly for 96 weeks SIM 125 mg subcutaneous injections weekly for 96 weeks Placebo subcutaneous injections weekly for 96 weeks
Period Title: Overall Study
Started 79 77 79
Completed 69 60 65
Not Completed 10 17 14
Reason Not Completed
Protocol Specified Criteria for Withdraw             0             4             0
Pregnancy             0             1             0
Investigator's Discretion             1             0             0
Withdrew Consent             5             5             5
Adverse Event             4             6             8
Lost to Follow-up             0             1             0
Randomized but Never Treated             0             0             1
Arm/Group Title SIM 75 mg SIM 125 mg Placebo Total
Hide Arm/Group Description SIM 75 mg subcutaneous injections weekly for 96 weeks SIM 125 mg subcutaneous injections weekly for 96 weeks Placebo subcutaneous injections weekly for 96 weeks Total of all reporting groups
Overall Number of Baseline Participants 79 77 78 234
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 77 participants 78 participants 234 participants
45  (11.3) 43  (10.1) 44  (12.8) 44  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 78 participants 234 participants
Female 27 25 33 85
Male 52 52 45 149
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 78 participants 234 participants
Hispanic or Latino 1 4 1 6
Not Hispanic or Latino 78 73 77 228
Unknown or Not Reported 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 78 participants 234 participants
American Indian or Alaska Native 0 0 1 1
Asian 0 1 3 4
Black 7 6 8 21
White 71 68 62 201
Other 1 2 4 7
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 77 participants 78 participants 234 participants
Canada 16 17 12 45
Sweden 1 0 0 1
Netherlands 2 1 2 5
Belgium 1 1 1 3
United States 42 35 43 120
Denmark 5 3 0 8
Italy 3 2 5 10
United Kingdom 5 9 6 20
Germany 3 2 5 10
Spain 0 3 2 5
France 1 4 2 7
Morphometric Quantitative Collagen (MQC)  
Mean (Standard Deviation)
Unit of measure:  Percentage of MQC
Number Analyzed 79 participants 77 participants 78 participants 234 participants
5.6  (5.09) 5.6  (3.36) 5.1  (3.98) 5.4  (4.19)
1.Primary Outcome
Title Change From Baseline in MQC on Liver Biopsy at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (participants who were randomized into the study and received at least 1 dose of study drug) with available data were analyzed.
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description:
SIM 75 mg subcutaneous injections weekly for 96 weeks
SIM 125 mg subcutaneous injections weekly for 96 weeks
Placebo subcutaneous injections weekly for 96 weeks
Overall Number of Participants Analyzed 61 61 62
Mean (Standard Deviation)
Unit of Measure: percentage of MQC
-0.5  (5.78) 0.5  (6.94) 0.0  (4.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SIM 75 mg, Placebo
Comments A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.3 to 1.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SIM 125 mg, Placebo
Comments A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1.0 to 3.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame First dose date up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included participants who received at least 1 dose of study drug.
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description:
SIM 75 mg subcutaneous injections weekly for 96 weeks
SIM 125 mg subcutaneous injections weekly for 96 weeks
Placebo subcutaneous injections weekly for 96 weeks
Overall Number of Participants Analyzed 79 77 78
Measure Type: Number
Unit of Measure: percentage of participants
5.1 7.8 10.3
3.Secondary Outcome
Title Study Drug Exposure
Hide Description The average SIM exposure was summarized.
Time Frame First dose date up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description:
SIM 75 mg subcutaneous injections weekly for 96 weeks
SIM 125 mg subcutaneous injections weekly for 96 weeks
Placebo subcutaneous injections weekly for 96 weeks
Overall Number of Participants Analyzed 79 77 78
Mean (Standard Deviation)
Unit of Measure: weeks
92.0  (15.33) 83.8  (26.12) 87.4  (22.35)
4.Secondary Outcome
Title Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality
Hide Description A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant [Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening)].
Time Frame First dose date up to Week 96 plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with at least one post-baseline measurement were analyzed.
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description:
SIM 75 mg subcutaneous injections weekly for 96 weeks
SIM 125 mg subcutaneous injections weekly for 96 weeks
Placebo subcutaneous injections weekly for 96 weeks
Overall Number of Participants Analyzed 79 77 78
Measure Type: Number
Unit of Measure: percentage of participants
Grade 1 11.4 16.9 17.9
Grade 2 26.6 20.8 25.6
Grade 3 48.1 46.8 48.7
Grade 4 11.4 13.0 7.7
Time Frame First dose date up to Week 96 plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who received at least one dose of study drug.
 
Arm/Group Title SIM 75 mg SIM 125 mg Placebo
Hide Arm/Group Description SIM 75 mg subcutaneous injections weekly for 96 weeks SIM 125 mg subcutaneous injections weekly for 96 weeks Placebo subcutaneous injections weekly for 96 weeks
All-Cause Mortality
SIM 75 mg SIM 125 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/77 (0.00%)   0/78 (0.00%) 
Hide Serious Adverse Events
SIM 75 mg SIM 125 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/79 (20.25%)   23/77 (29.87%)   21/78 (26.92%) 
Blood and lymphatic system disorders       
Leukocytosis  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Cardiac disorders       
Acute myocardial infarction  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Coronary artery disease  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Myocardial infarction  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Ventricular tachycardia  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  2/79 (2.53%)  3/77 (3.90%)  0/78 (0.00%) 
Abdominal pain upper  1  1/79 (1.27%)  1/77 (1.30%)  0/78 (0.00%) 
Colitis  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Colitis ulcerative  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Diverticular perforation  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Haematemesis  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Haematochezia  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Ileus  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Melaena  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Oesophageal varices haemorrhage  1  2/79 (2.53%)  0/77 (0.00%)  0/78 (0.00%) 
Pancreatitis  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Pancreatitis acute  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Upper gastrointestinal haemorrhage  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
General disorders       
Pyrexia  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Systemic inflammatory response syndrome  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Hepatobiliary disorders       
Bile duct stenosis  1  1/79 (1.27%)  0/77 (0.00%)  1/78 (1.28%) 
Bile duct stone  1  0/79 (0.00%)  1/77 (1.30%)  1/78 (1.28%) 
Cholangitis  1  6/79 (7.59%)  5/77 (6.49%)  3/78 (3.85%) 
Cholangitis acute  1  0/79 (0.00%)  1/77 (1.30%)  1/78 (1.28%) 
Cholecystitis  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Cholecystitis acute  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Cholelithiasis  1  1/79 (1.27%)  1/77 (1.30%)  1/78 (1.28%) 
Gallbladder perforation  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Jaundice cholestatic  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Portal vein thrombosis  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Infections and infestations       
Cholangitis infective  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Diverticulitis  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Gastrointestinal infection  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Infected skin ulcer  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Pelvic abscess  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Peritonitis  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Pharyngitis  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Pneumonia  1  0/79 (0.00%)  0/77 (0.00%)  2/78 (2.56%) 
Sepsis  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Septic shock  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Streptococcal bacteraemia  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Injury, poisoning and procedural complications       
Intestinal anastomosis complication  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Post procedural complication  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Post procedural haemorrhage  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Postoperative fever  1  0/79 (0.00%)  1/77 (1.30%)  1/78 (1.28%) 
Procedural complication  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Procedural pain  1  0/79 (0.00%)  1/77 (1.30%)  1/78 (1.28%) 
Stoma obstruction  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Investigations       
Blood bilirubin increased  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Liver function test increased  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Metabolism and nutrition disorders       
Failure to thrive  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  1/79 (1.27%)  1/77 (1.30%)  0/78 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Benign biliary neoplasm  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Cholangiocarcinoma  1  0/79 (0.00%)  1/77 (1.30%)  2/78 (2.56%) 
Hepatocellular carcinoma  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Lipoma  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Rectal adenoma  1  0/79 (0.00%)  1/77 (1.30%)  0/78 (0.00%) 
Psychiatric disorders       
Depression  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Post-traumatic stress disorder  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Renal and urinary disorders       
Acute kidney injury  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Calculus urinary  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Renal colic  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Respiratory failure  1  0/79 (0.00%)  0/77 (0.00%)  1/78 (1.28%) 
Skin and subcutaneous tissue disorders       
Drug eruption  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
Vascular disorders       
Thrombophlebitis  1  1/79 (1.27%)  0/77 (0.00%)  0/78 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SIM 75 mg SIM 125 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   71/79 (89.87%)   72/77 (93.51%)   75/78 (96.15%) 
Blood and lymphatic system disorders       
Anaemia  1  4/79 (5.06%)  3/77 (3.90%)  4/78 (5.13%) 
Gastrointestinal disorders       
Abdominal discomfort  1  4/79 (5.06%)  4/77 (5.19%)  3/78 (3.85%) 
Abdominal distension  1  4/79 (5.06%)  3/77 (3.90%)  6/78 (7.69%) 
Abdominal pain  1  13/79 (16.46%)  18/77 (23.38%)  17/78 (21.79%) 
Abdominal pain lower  1  2/79 (2.53%)  3/77 (3.90%)  4/78 (5.13%) 
Abdominal pain upper  1  18/79 (22.78%)  14/77 (18.18%)  18/78 (23.08%) 
Colitis ulcerative  1  1/79 (1.27%)  1/77 (1.30%)  5/78 (6.41%) 
Constipation  1  7/79 (8.86%)  1/77 (1.30%)  7/78 (8.97%) 
Diarrhoea  1  19/79 (24.05%)  15/77 (19.48%)  15/78 (19.23%) 
Dyspepsia  1  2/79 (2.53%)  2/77 (2.60%)  9/78 (11.54%) 
Gastrooesophageal reflux disease  1  0/79 (0.00%)  1/77 (1.30%)  5/78 (6.41%) 
Haemorrhoids  1  4/79 (5.06%)  1/77 (1.30%)  0/78 (0.00%) 
Nausea  1  16/79 (20.25%)  17/77 (22.08%)  17/78 (21.79%) 
Rectal haemorrhage  1  5/79 (6.33%)  2/77 (2.60%)  3/78 (3.85%) 
Varices oesophageal  1  2/79 (2.53%)  5/77 (6.49%)  4/78 (5.13%) 
Vomiting  1  9/79 (11.39%)  5/77 (6.49%)  7/78 (8.97%) 
General disorders       
Asthenia  1  1/79 (1.27%)  4/77 (5.19%)  3/78 (3.85%) 
Fatigue  1  19/79 (24.05%)  21/77 (27.27%)  16/78 (20.51%) 
Influenza like illness  1  3/79 (3.80%)  4/77 (5.19%)  4/78 (5.13%) 
Injection site erythema  1  2/79 (2.53%)  5/77 (6.49%)  0/78 (0.00%) 
Injection site pain  1  4/79 (5.06%)  0/77 (0.00%)  3/78 (3.85%) 
Pain  1  0/79 (0.00%)  6/77 (7.79%)  5/78 (6.41%) 
Pyrexia  1  11/79 (13.92%)  10/77 (12.99%)  13/78 (16.67%) 
Hepatobiliary disorders       
Cholangitis  1  6/79 (7.59%)  6/77 (7.79%)  4/78 (5.13%) 
Jaundice  1  5/79 (6.33%)  4/77 (5.19%)  3/78 (3.85%) 
Infections and infestations       
Bronchitis  1  2/79 (2.53%)  3/77 (3.90%)  7/78 (8.97%) 
Gastroenteritis  1  2/79 (2.53%)  5/77 (6.49%)  2/78 (2.56%) 
Gastroenteritis viral  1  5/79 (6.33%)  1/77 (1.30%)  4/78 (5.13%) 
Influenza  1  5/79 (6.33%)  2/77 (2.60%)  7/78 (8.97%) 
Lower respiratory tract infection  1  5/79 (6.33%)  0/77 (0.00%)  1/78 (1.28%) 
Nasopharyngitis  1  19/79 (24.05%)  17/77 (22.08%)  14/78 (17.95%) 
Sinusitis  1  5/79 (6.33%)  11/77 (14.29%)  5/78 (6.41%) 
Upper respiratory tract infection  1  11/79 (13.92%)  9/77 (11.69%)  10/78 (12.82%) 
Urinary tract infection  1  6/79 (7.59%)  4/77 (5.19%)  4/78 (5.13%) 
Injury, poisoning and procedural complications       
Contusion  1  4/79 (5.06%)  3/77 (3.90%)  0/78 (0.00%) 
Procedural pain  1  4/79 (5.06%)  7/77 (9.09%)  7/78 (8.97%) 
Investigations       
Blood bilirubin increased  1  4/79 (5.06%)  2/77 (2.60%)  3/78 (3.85%) 
Metabolism and nutrition disorders       
Decreased appetite  1  4/79 (5.06%)  3/77 (3.90%)  5/78 (6.41%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  5/79 (6.33%)  12/77 (15.58%)  10/78 (12.82%) 
Back pain  1  8/79 (10.13%)  8/77 (10.39%)  9/78 (11.54%) 
Flank pain  1  0/79 (0.00%)  2/77 (2.60%)  4/78 (5.13%) 
Muscle spasms  1  7/79 (8.86%)  2/77 (2.60%)  4/78 (5.13%) 
Musculoskeletal pain  1  4/79 (5.06%)  3/77 (3.90%)  2/78 (2.56%) 
Myalgia  1  2/79 (2.53%)  7/77 (9.09%)  1/78 (1.28%) 
Pain in extremity  1  7/79 (8.86%)  2/77 (2.60%)  4/78 (5.13%) 
Nervous system disorders       
Dizziness  1  6/79 (7.59%)  5/77 (6.49%)  4/78 (5.13%) 
Headache  1  18/79 (22.78%)  12/77 (15.58%)  17/78 (21.79%) 
Psychiatric disorders       
Anxiety  1  2/79 (2.53%)  3/77 (3.90%)  4/78 (5.13%) 
Insomnia  1  5/79 (6.33%)  5/77 (6.49%)  4/78 (5.13%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/79 (17.72%)  7/77 (9.09%)  7/78 (8.97%) 
Dyspnoea  1  5/79 (6.33%)  3/77 (3.90%)  1/78 (1.28%) 
Oropharyngeal pain  1  5/79 (6.33%)  3/77 (3.90%)  4/78 (5.13%) 
Sinus congestion  1  3/79 (3.80%)  4/77 (5.19%)  1/78 (1.28%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  21/79 (26.58%)  22/77 (28.57%)  31/78 (39.74%) 
Rash  1  10/79 (12.66%)  2/77 (2.60%)  3/78 (3.85%) 
Vascular disorders       
Hypertension  1  3/79 (3.80%)  2/77 (2.60%)  4/78 (5.13%) 
1
Term from vocabulary, MedDRA 19.1
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
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Shea P, Hirschfield G, Shiffman M, McColgan B, Goodman Z, Myers, R, et al. Common variation near glial-derived neurotrophic factor is associated with progression of hepatic collagen content in a genome-wide association study of liver fibrosis phenotypes in patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S4-S5.
Muir A, Goodman Z, Levy C, Janssen H, Montano-Loza A, Bowlus C, et al. Efficacy and safety of simtuzumab for the treatment of primary sclerosing cholangitis: results of a phase 2b, dose-ranging, randomized, placebo-controlled trial. J Hepatol 2017; 66 (1): S73.
Bowlus CL, Patel K, Hirschfield G, Guha I, Chapman R, Chazouilleres O, et al. Prospective validation of the Enhanced Liver Fibrosis test for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S359.
Levy C, Eksteen B, Shiffman M, Janssen H, Montano-Loza A, Ding D, et al. Prospective validation of serum alkaline phosphatase for the prediction of disease progression in a randomized trial of patients with primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S360-S361.
Levy C, Shiffman M, Caldwell S, Luketic V, Invernizzi P, Minuk G, et al. Serum fibroblast growth factor 19, 7α-Hydroxy-4-Cholesten-3-one, and bile acids and their associations with clinical characteristics in primary sclerosing cholangitis. J Hepatol 2017; 66 (1): S361.
French D, Huntzicker EG, Goodman ZD, Shea PR, Ding D, Aguilar Schall, RE, et al. Hepatic expression of lysyl oxidase-like-2 (LOXL2) in primary sclerosing cholangitis (PSC). Hepatol 2016; 64 (1): 194A.
Bowlus CL, Montano-Loza AJ, Invernizzi P, Chazouilleres O, Hirschfield G, Metselaar HJ, et al. Liver stiffness measurement by transient elastography for the prediction of fibrosis in patients with primary sclerosing cholangitis in a randomized trial of simtuzumab. J Hepatol 2016; 64 (2): S434.
Goodman Z, Patel K, Guha I, Hameed B, Kowdley K, Alaparthi L, et al. Correlations between hepatic morphometric collagen content, histologic fibrosis stage, and serum markers in patients with primary sclerosing cholangitis (PSC). J Hepatol 2016; 64 (2): S652-S653.
Muir AJ, Goodman Z, Bowlus CL, Caldwell S, Invernizzi P, Luketic V, et al. Serum lysyl oxidase-like-2 (SLOXL2) levels correlate with disease severity in patients with primary sclerosing cholangitis. J Hepatol 2016; 64 (2): S428.
Shea PR, Eksteen B, Hirschfield GM, Shiffman ML, Janssen HLA, Montano-Loza AJ, et al. Genome-wide association study (GWAS) of liver fibrosis phenotypes in patients with primary sclerosing cholangitis (PSC) reveals common genetic variation influencing serum levels of lysyl oxidase-like-2 (LOXL2). J Hepatol 2016; 64 (2): S180-S182.
Manns MP, Eksteen B, Shiffman ML, Levy C, Kowdley KV, Montano-Loza AJ, et al. Association between elevated serum IgG4 (sIgG4) concentrations and the phenotype of patients with primary sclerosing cholangitis (PSC). Hepatol 2015; 62 (1): 515A.
Bowlus CL, Patel K, Chuha IN, Chapman RW, Chazouilleres O, Chalasani NP, et al. Validation of serum fibrosis marker panels in patients with primary sclerosing cholangitis (PSC) in a randomized trial of simtuzumab. Hepatol 2015; 62 (1): 519A.
French D, Goodman ZD, Huntzicker EG, Newstrom D, Karnik S, Smith V, et al. Expression of matrix metalloproteinase 9 (MMP9) and the apoptosis signal-regulating kinase 1 (ASK1) pathway activation marker, phospho-P38 (p-P38), in primary sclerosing cholangitis (PSC). Hepatol 2015; 62 (1): 523A-524A.
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01672853    
Other Study ID Numbers: GS-US-321-0102
2012-002473-61 ( EudraCT Number )
First Submitted: August 22, 2012
First Posted: August 27, 2012
Results First Submitted: October 3, 2019
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019