Trial Outcomes & Findings for 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 (NCT NCT02462967)
NCT ID: NCT02462967
Last Updated: 2020-10-08
Results Overview
Change in Portal Pressure at Year 1 from Baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
1 year
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
2 mg/kg GR MD 02
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
|
8 mg/kg GR MD 02
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
|
Placebo
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 Study
STARTED
|
54
|
54
|
54
|
|
Overall Study
COMPLETED
|
52
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
54 participants
n=7 Participants
|
54 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Portal Pressure
|
12.36 mm Hg
STANDARD_DEVIATION 4.288 • n=5 Participants
|
12.72 mm Hg
STANDARD_DEVIATION 4.203 • n=7 Participants
|
11.59 mm Hg
STANDARD_DEVIATION 3.994 • n=5 Participants
|
12.22 mm Hg
STANDARD_DEVIATION 4.162 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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.
Change in Portal Pressure at Year 1 from Baseline
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=48 Participants
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
|
8 mg/kg GR MD 02
n=45 Participants
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
|
Placebo
n=50 Participants
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
|
|---|---|---|---|
|
Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year)
|
-0.39 mm HG
Standard Deviation 4.018
|
-0.24 mm HG
Standard Deviation 3.100
|
0.19 mm HG
Standard Deviation 3.240
|
SECONDARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=46 Participants
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
|
8 mg/kg GR MD 02
n=41 Participants
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
|
Placebo
n=45 Participants
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
|
|---|---|---|---|
|
The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA
|
1.2 Percent Area (%)
Standard Deviation 5.54
|
0.1 Percent Area (%)
Standard Deviation 5.68
|
1.3 Percent Area (%)
Standard Deviation 8.22
|
SECONDARY outcome
Timeframe: 1 yearThe 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.
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
|
|---|---|---|---|
|
The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis
|
17 Participants
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 14 to 28 days after final infusionThe 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.
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
|
|---|---|---|---|
|
The Baseline-adjusted Mean Change in Liver Stiffness
|
-0.59 Kilopascals, kPa
Standard Deviation 2.00
|
-2.76 Kilopascals, kPa
Standard Deviation 2.02
|
-0.79 Kilopascals, kPa
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: 14 to 28 days after final infusionThe 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.
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
|
|---|---|---|---|
|
The Baseline-adjusted Mean Change in Methacetin Breath Test (MBT), Measured in Percentage
|
-40.51 percent
Standard Deviation 34.45
|
-20.57 percent
Standard Deviation 38.00
|
-51.00 percent
Standard Deviation 35.17
|
SECONDARY outcome
Timeframe: 1 yearThe 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).
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
|
|---|---|---|---|
|
The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Brunt-Kleiner Assessment on Liver Biopsy Histopathological Staging of Fibrosis
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe 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
Outcome measures
| Measure |
2 mg/kg GR MD 02
n=54 Participants
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
|
8 mg/kg GR MD 02
n=54 Participants
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
|
Placebo
n=54 Participants
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
|
|---|---|---|---|
|
The Number (Percentage) of Subjects That Develop a Clinical Complication of Cirrhosis
|
10 Participants
|
11 Participants
|
12 Participants
|
Adverse Events
2 mg/kg GR MD 02
Serious events: 10 serious events
Other events: 52 other events
Deaths: 1 deaths
8 mg/kg GR MD 02
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg/kg GR MD 02
n=53 participants at risk
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
|
8 mg/kg GR MD 02
n=54 participants at risk
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
|
Placebo
n=54 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.8%
2/53 • Number of events 2 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
1.9%
1/53 • Number of events 1 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
OESOPHAGEAL HAEMORRHAGE
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Infections and infestations
SEPSIS
|
0.00%
0/53 • 1 year
|
3.7%
2/54 • Number of events 2 • 1 year
|
0.00%
0/54 • 1 year
|
|
Infections and infestations
ABSCESS OF EYELID
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Infections and infestations
GASTROENTERITIS SALMONELLA
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/53 • 1 year
|
3.7%
2/54 • Number of events 2 • 1 year
|
0.00%
0/54 • 1 year
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
3.7%
2/54 • Number of events 2 • 1 year
|
|
General disorders
HERNIA PAIN
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
General disorders
PYREXIA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
DURAL TEAR
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
STOMA COMPLICATION
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/53 • 1 year
|
0.00%
0/54 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/53 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.9%
1/53 • Number of events 1 • 1 year
|
0.00%
0/54 • 1 year
|
0.00%
0/54 • 1 year
|
Other adverse events
| Measure |
2 mg/kg GR MD 02
n=53 participants at risk
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
|
8 mg/kg GR MD 02
n=54 participants at risk
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
|
Placebo
n=54 participants at risk
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
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
26.4%
14/53 • Number of events 14 • 1 year
|
9.3%
5/54 • Number of events 5 • 1 year
|
14.8%
8/54 • Number of events 8 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
15.1%
8/53 • Number of events 8 • 1 year
|
11.1%
6/54 • Number of events 6 • 1 year
|
16.7%
9/54 • Number of events 9 • 1 year
|
|
Infections and infestations
Sinusitis
|
11.3%
6/53 • Number of events 6 • 1 year
|
13.0%
7/54 • Number of events 7 • 1 year
|
7.4%
4/54 • Number of events 4 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
8/53 • Number of events 8 • 1 year
|
7.4%
4/54 • Number of events 4 • 1 year
|
9.3%
5/54 • Number of events 5 • 1 year
|
|
Infections and infestations
Bronchitis
|
13.2%
7/53 • Number of events 7 • 1 year
|
5.6%
3/54 • Number of events 3 • 1 year
|
9.3%
5/54 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
26.4%
14/53 • Number of events 14 • 1 year
|
14.8%
8/54 • Number of events 8 • 1 year
|
20.4%
11/54 • Number of events 11 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
22.6%
12/53 • Number of events 12 • 1 year
|
14.8%
8/54 • Number of events 8 • 1 year
|
20.4%
11/54 • Number of events 11 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.1%
8/53 • Number of events 8 • 1 year
|
14.8%
8/54 • Number of events 8 • 1 year
|
24.1%
13/54 • Number of events 13 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
7/53 • Number of events 7 • 1 year
|
13.0%
7/54 • Number of events 7 • 1 year
|
3.7%
2/54 • Number of events 2 • 1 year
|
|
Eye disorders
Abdominal pain
|
9.4%
5/53 • Number of events 5 • 1 year
|
5.6%
3/54 • Number of events 3 • 1 year
|
13.0%
7/54 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.3%
6/53 • Number of events 6 • 1 year
|
16.7%
9/54 • Number of events 9 • 1 year
|
1.9%
1/54 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.1%
8/53 • Number of events 8 • 1 year
|
5.6%
3/54 • Number of events 3 • 1 year
|
7.4%
4/54 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
4/53 • Number of events 4 • 1 year
|
7.4%
4/54 • Number of events 4 • 1 year
|
11.1%
6/54 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
3/53 • Number of events 3 • 1 year
|
13.0%
7/54 • Number of events 7 • 1 year
|
3.7%
2/54 • Number of events 2 • 1 year
|
|
General disorders
Fatigue
|
17.0%
9/53 • Number of events 9 • 1 year
|
16.7%
9/54 • Number of events 9 • 1 year
|
18.5%
10/54 • Number of events 10 • 1 year
|
|
General disorders
Oedema peripheral
|
15.1%
8/53 • Number of events 8 • 1 year
|
7.4%
4/54 • Number of events 4 • 1 year
|
13.0%
7/54 • Number of events 7 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
5/53 • Number of events 5 • 1 year
|
9.3%
5/54 • Number of events 5 • 1 year
|
11.1%
6/54 • Number of events 6 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
18.9%
10/53 • Number of events 10 • 1 year
|
5.6%
3/54 • Number of events 3 • 1 year
|
11.1%
6/54 • Number of events 6 • 1 year
|
|
Nervous system disorders
Headache
|
17.0%
9/53 • Number of events 9 • 1 year
|
11.1%
6/54 • Number of events 6 • 1 year
|
16.7%
9/54 • Number of events 9 • 1 year
|
|
Nervous system disorders
Dizziness
|
3.8%
2/53 • Number of events 2 • 1 year
|
9.3%
5/54 • Number of events 5 • 1 year
|
16.7%
9/54 • Number of events 9 • 1 year
|
Additional Information
Vice President of Regulatory Affairs
Galectin Therapeutics
Phone: 678-620-3186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place