Trial · NCT02462967
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
NCT02462967, Phase 2, Completed, Galectin Therapeutics Inc.; results first posted 2020-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02462967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02462967
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT02462967
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Galectin Therapeutics Inc.
- Conditions
- Hypertension, Portal
- Interventions
- GR-MD-02, Placebo
- First posted
- 2015-06-04
- Last updated
- 2020-10-08
- Results first posted
- 2020-10-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year) | 1 year | Change in Portal Pressure at Year 1 from Baseline |
| Secondary | The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA | 1 year | 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. |
| Secondary | The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis | 1 year | 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. |
| Secondary | The Baseline-adjusted Mean Change in Liver Stiffness | 14 to 28 days after final infusion | 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. |
| Secondary | The Baseline-adjusted Mean Change in Methacetin Breath Test (MBT), Measured in Percentage | 14 to 28 days after final infusion | 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. |
| Secondary | The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Brunt-Kleiner Assessment on Liver Biopsy Histopathological Staging of Fibrosis | 1 year | 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). |
| Secondary | The Number (Percentage) of Subjects That Develop a Clinical Complication of Cirrhosis | 1 year | 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 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year) | 1 year | 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. | mm HG | MEAN |
| SECONDARY | The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA | 1 year | Percent Area (%) | MEAN | |
| SECONDARY | The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Baseline-adjusted Mean Change in Liver Stiffness | 14 to 28 days after final infusion | Kilopascals, kPa | MEAN | |
| SECONDARY | The Baseline-adjusted Mean Change in Methacetin Breath Test (MBT), Measured in Percentage | 14 to 28 days after final infusion | percent | MEAN | |
| SECONDARY | The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Brunt-Kleiner Assessment on Liver Biopsy Histopathological Staging of Fibrosis | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number (Percentage) of Subjects That Develop a Clinical Complication of Cirrhosis | 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year) | 2 mg/kg GR MD 02 | -0.39 | Standard Deviation 4.018 | mm HG | |
| Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year) | 8 mg/kg GR MD 02 | -0.24 | Standard Deviation 3.100 | mm HG | |
| Change in Portal Pressure at Year 1 (Change in HVPG From Baseline and 1 Year) | Placebo | 0.19 | Standard Deviation 3.240 | mm HG | |
| The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA | 2 mg/kg GR MD 02 | 1.2 | Standard Deviation 5.54 | Percent Area (%) | |
| The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA | 8 mg/kg GR MD 02 | 0.1 | Standard Deviation 5.68 | Percent Area (%) | |
| The Baseline-adjusted Mean Change in the Collagen Proportional Area (%), CPA | Placebo | 1.3 | Standard Deviation 8.22 | Percent Area (%) | |
| The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis | 2 mg/kg GR MD 02 | 17 | Participants | ||
| The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis | 8 mg/kg GR MD 02 | 13 | Participants | ||
| The Number (Percentage) of Subjects Who Have at Least a One Stage Change in Ishak Assessment From Liver Biology Histopathology. Histopathological Staging of Fibrosis | Placebo | 14 | Participants | ||
| The Baseline-adjusted Mean Change in Liver Stiffness | 2 mg/kg GR MD 02 | -0.59 | Standard Deviation 2.00 | Kilopascals, kPa |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2 mg/kg GR MD 02 | 54 | |
| Overall Study | STARTED | 8 mg/kg GR MD 02 | 54 | |
| Overall Study | STARTED | Placebo | 54 | |
| Overall Study | COMPLETED | 2 mg/kg GR MD 02 | 52 | |
| Overall Study | COMPLETED | 8 mg/kg GR MD 02 | 48 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | NOT COMPLETED | 2 mg/kg GR MD 02 | 2 | |
| Overall Study | NOT COMPLETED | 8 mg/kg GR MD 02 | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events153
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | 2 mg/kg GR MD 02 | 14 | 53 | 14 |
| other | Nasopharyngitis | Infections and infestations | 8 mg/kg GR MD 02 | 5 | 54 | 5 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 8 | 54 | 8 |
| other | Urinary tract infection | Infections and infestations | 2 mg/kg GR MD 02 | 8 | 53 | 8 |
| other | Urinary tract infection | Infections and infestations | 8 mg/kg GR MD 02 | 6 | 54 | 6 |
| other | Urinary tract infection | Infections and infestations | Placebo | 9 | 54 | 9 |
| other | Sinusitis | Infections and infestations | 2 mg/kg GR MD 02 | 6 | 53 | 6 |
| other | Sinusitis | Infections and infestations | 8 mg/kg GR MD 02 | 7 | 54 | 7 |
| other | Sinusitis | Infections and infestations | Placebo | 4 | 54 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | 2 mg/kg GR MD 02 | 8 | 53 | 8 |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2 mg/kg GR MD 02 | 1 | 53 |
| Total, all-cause mortality | 8 mg/kg GR MD 02 | 0 | 54 |
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, other adverse events | 2 mg/kg GR MD 02 | 52 | 53 |
| Total, other adverse events | 8 mg/kg GR MD 02 | 48 | 54 |
| Total, other adverse events | Placebo | 53 | 54 |
| Total, serious adverse events | 2 mg/kg GR MD 02 | 10 | 53 |
| Total, serious adverse events | 8 mg/kg GR MD 02 | 16 | 54 |
| Total, serious adverse events | Placebo | 12 | 54 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02462967
GET https://conductscience.org/api/trials/v1/NCT02462967/results?page=2