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Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis (NASH-CX)

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: NCT02462967
Recruitment Status : Completed
First Posted : June 4, 2015
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Dr. Naga Chalasani, MD, Indiana University
Dr. Stephen A. Harrison, MD, Brooke Army Medical Center
Information provided by (Responsible Party):
Galectin Therapeutics Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension, Portal
Interventions Drug: GR-MD-02
Drug: Placebo
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Period Title: Overall Study
Started 54 54 54
Completed 52 48 51
Not Completed 2 6 3
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo Total
Hide Arm/Group Description

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Total of all reporting groups
Overall Number of Baseline Participants 54 54 54 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 54 participants 54 participants 162 participants
59.2  (7.54) 57.1  (9.30) 58.4  (8.51) 58.3  (8.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
Female
34
  63.0%
43
  79.6%
36
  66.7%
113
  69.8%
Male
20
  37.0%
11
  20.4%
18
  33.3%
49
  30.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
Hispanic or Latino
7
  13.0%
13
  24.1%
8
  14.8%
28
  17.3%
Not Hispanic or Latino
47
  87.0%
41
  75.9%
46
  85.2%
134
  82.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
American Indian or Alaska Native 0 0 0 0
Asian 1 0 0 1
Native Hawaiian or Other Pacific Islander 0 1 0 1
Black or African American 0 0 0 0
White 53 52 54 159
More than one race 0 0 0 0
Unknown or Not Reported 0 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 54 participants 54 participants 162 participants
54 54 54 162
Portal Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 54 participants 54 participants 54 participants 162 participants
12.36  (4.288) 12.72  (4.203) 11.59  (3.994) 12.22  (4.162)
1.Primary Outcome
Title Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year)
Hide Description Change in Portal Pressure at Year 1 from Baseline
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is performed with the Full Analysis Set (FAS) in accordance with the Protocol and the Statistical Analysis Plan (SAP). The criteria for the Full Analysis Set is specified in the SAP and resulted in the Overall Number of Participants Analyzed being less than the numbers in the Participant Flow module.
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 48 45 50
Mean (Standard Deviation)
Unit of Measure: mm HG
-0.39  (4.018) -0.24  (3.100) 0.19  (3.240)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA
Hide Description The baseline-adjusted mean change in the CPA at 1 year as determined by digital morphometric analysis of liver biopsies. Collagen proportionate area (CPA) measurement is a technique that quantifies fibrous tissue in liver biopsies by measuring the amount of collagen deposition as a proportion of the total biopsy area. CPA predicts clinical outcomes in patients with liver disease and can sub-classify cirrhosis.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 46 41 45
Mean (Standard Deviation)
Unit of Measure: Percent Area (%)
1.2  (5.54) 0.1  (5.68) 1.3  (8.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.921
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis
Hide Description The number (percentage) of subjects who have at least a one stage change in Ishak histopathological staging of fibrosis at 1 year as assessed on liver biopsy. Liver biopsy is the accepted standard for histologic assessment of liver disease activity and fibrosis. Ishak assessments on liver biopsy range from 0=no fibrosis to 6=cirrhosis.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 54 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
17
  31.5%
13
  24.1%
14
  25.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Baseline-adjusted Mean Change in Liver Stiffness
Hide Description

The baseline-adjusted mean change in liver stiffness as determined by FibroScan score 14 to 28 days after final infusion.

FibroScan is a device that measures scarring by measuring the stiffness of your liver.The fibrosis result is measured in kilopascals (kPa) It's normally between 2 and 6 kPa. The highest possible result is 75 kPa. Many people with liver disease(s) have a result that's higher than the normal range.

Time Frame 14 to 28 days after final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 54 54 54
Mean (Standard Deviation)
Unit of Measure: Kilopascals, kPa
-0.59  (2.00) -2.76  (2.02) -0.79  (2.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.943
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title The Baseline-adjusted Mean Change in Methacetin Breath Test (MBT), Measured in Percentage
Hide Description The baseline-adjusted mean change in the metabolic capacity of the liver as determined the methacetin breath test (MBT) at 14 to 28 days after final infusion. The results obtained from the MBT medical device are expressed as delta over baseline (DOB), which expresses the change in 13CO2/12CO2 ratio in comparison to the baseline measurement. It can be transformed into the percentage of 13C dose recovered over time (PDR) after the ingestion of Methacetin, and the cumulative PDR (CPDR), the rate at which 13C substrate is metabolized, derived from the breath 13C/12C ratio.
Time Frame 14 to 28 days after final infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 54 54 54
Mean (Standard Deviation)
Unit of Measure: percent
-40.51  (34.45) -20.57  (38.00) -51.00  (35.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Brunt-Kleiner Assessment on Liver Biopsy Histopathological Staging of Fibrosis
Hide Description The number (percentage) of subjects who have at least a one stage change in Brunt-Kleiner histopathological staging of fibrosis at 1 year as assessed on liver biopsy. Liver biopsy is the accepted standard for histologic assessment of liver disease activity and fibrosis. Brunt-Kleiner assessments on liver biopsy range from 0 (absent) to 4 (cirrhosis).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 54 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.6%
2
   3.7%
1
   1.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title The Number (Percentage) of Subjects That Develop a Clinical Complication of Cirrhosis
Hide Description The number (percentage) of subjects with progression of cirrhosis at 1 year, defined as the development of any of the following clinical complications: esophageal variceal hemorrhage or portal hypertensive gastropathy hemorrhage (confirmed by endoscopy or interventional radiology); clinically apparent ascites; spontaneous bacterial peritonitis; overt hepatic encephalopathy; an increase in Child-Turcotte-Pugh score ≥2 points; newly diagnosed varices in a subject without prior varices; progression from small to medium or large varices; qualification for liver transplant defined as a Model for End-Stage Liver Disease (MELD) score ≥15; listing for a liver transplant or the performance of a liver transplant; liver-related mortality
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description:

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

Overall Number of Participants Analyzed 54 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
10
  18.5%
11
  20.4%
12
  22.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 8 mg/kg GR MD 02, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Hide Arm/Group Description

GR MD 02 in a dose of 2 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

GR MD 02 in a dose of 8 mg/kg lean body mass administered every other week over a 52 week period for a total of 26 infusions

GR-MD-02: GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3

Phosphate buffered saline solution administered every other week over a 52 week period for a total of 26 infusions

Placebo: Placebo for GR-MD-02

All-Cause Mortality
2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/53 (1.89%)      0/54 (0.00%)      0/54 (0.00%)    
Hide Serious Adverse Events
2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/53 (18.87%)      16/54 (29.63%)      12/54 (22.22%)    
Blood and lymphatic system disorders       
ANAEMIA   0/53 (0.00%)  0 1/54 (1.85%)  1 2/54 (3.70%)  2
Cardiac disorders       
SUPRAVENTRICULAR TACHYCARDIA   0/53 (0.00%)  0 2/54 (3.70%)  2 0/54 (0.00%)  0
ARTERIOSCLEROSIS CORONARY ARTERY   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
ATRIAL FIBRILLATION   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
CARDIAC FAILURE CONGESTIVE   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN   2/53 (3.77%)  2 0/54 (0.00%)  0 1/54 (1.85%)  1
HAEMATEMESIS   1/53 (1.89%)  1 1/54 (1.85%)  1 0/54 (0.00%)  0
DIARRHOEA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
GASTROINTESTINAL HAEMORRHAGE   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
HAEMATOCHEZIA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
OESOPHAGEAL HAEMORRHAGE   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
PANCREATITIS ACUTE   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
General disorders       
HERNIA PAIN   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
NON-CARDIAC CHEST PAIN   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
PYREXIA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
Infections and infestations       
SEPSIS   0/53 (0.00%)  0 2/54 (3.70%)  2 0/54 (0.00%)  0
ABSCESS OF EYELID   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
CELLULITIS   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
ESCHERICHIA BACTERAEMIA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
GASTROENTERITIS SALMONELLA   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
PNEUMONIA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
Injury, poisoning and procedural complications       
DURAL TEAR   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
STOMA COMPLICATION   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
Metabolism and nutrition disorders       
HYPONATRAEMIA   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders       
ARTHRALGIA   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
OSTEOARTHRITIS   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
SQUAMOUS CELL CARCINOMA OF SKIN   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders       
HYPOAESTHESIA   0/53 (0.00%)  0 0/54 (0.00%)  0 1/54 (1.85%)  1
TRANSIENT ISCHAEMIC ATTACK   0/53 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
PULMONARY EMBOLISM   1/53 (1.89%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2 mg/kg GR MD 02 8 mg/kg GR MD 02 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/53 (98.11%)      48/54 (88.89%)      53/54 (98.15%)    
Eye disorders       
Abdominal pain   5/53 (9.43%)  5 3/54 (5.56%)  3 7/54 (12.96%)  7
Gastrointestinal disorders       
Nausea   14/53 (26.42%)  14 8/54 (14.81%)  8 11/54 (20.37%)  11
Diarrhoea   12/53 (22.64%)  12 8/54 (14.81%)  8 11/54 (20.37%)  11
Abdominal pain upper   8/53 (15.09%)  8 8/54 (14.81%)  8 13/54 (24.07%)  13
Vomiting   7/53 (13.21%)  7 7/54 (12.96%)  7 2/54 (3.70%)  2
General disorders       
Fatigue   9/53 (16.98%)  9 9/54 (16.67%)  9 10/54 (18.52%)  10
Oedema peripheral   8/53 (15.09%)  8 4/54 (7.41%)  4 7/54 (12.96%)  7
Infections and infestations       
Nasopharyngitis   14/53 (26.42%)  14 5/54 (9.26%)  5 8/54 (14.81%)  8
Urinary tract infection   8/53 (15.09%)  8 6/54 (11.11%)  6 9/54 (16.67%)  9
Sinusitis   6/53 (11.32%)  6 7/54 (12.96%)  7 4/54 (7.41%)  4
Upper respiratory tract infection   8/53 (15.09%)  8 4/54 (7.41%)  4 5/54 (9.26%)  5
Bronchitis   7/53 (13.21%)  7 3/54 (5.56%)  3 5/54 (9.26%)  5
Injury, poisoning and procedural complications       
Contusion   10/53 (18.87%)  10 3/54 (5.56%)  3 6/54 (11.11%)  6
Musculoskeletal and connective tissue disorders       
Arthralgia   6/53 (11.32%)  6 9/54 (16.67%)  9 1/54 (1.85%)  1
Muscle spasms   8/53 (15.09%)  8 3/54 (5.56%)  3 4/54 (7.41%)  4
Pain in extremity   4/53 (7.55%)  4 4/54 (7.41%)  4 6/54 (11.11%)  6
Back pain   3/53 (5.66%)  3 7/54 (12.96%)  7 2/54 (3.70%)  2
Nervous system disorders       
Headache   9/53 (16.98%)  9 6/54 (11.11%)  6 9/54 (16.67%)  9
Dizziness   2/53 (3.77%)  2 5/54 (9.26%)  5 9/54 (16.67%)  9
Skin and subcutaneous tissue disorders       
Rash   5/53 (9.43%)  5 5/54 (9.26%)  5 6/54 (11.11%)  6
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President of Regulatory Affairs
Organization: Galectin Therapeutics
Phone: 678-620-3186
EMail: horton@galectintherapeutics.com
Layout table for additonal information
Responsible Party: Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02462967    
Other Study ID Numbers: GT-026
First Submitted: June 2, 2015
First Posted: June 4, 2015
Results First Submitted: August 17, 2020
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020