| Trial ID: | L0420 |
| Source ID: | EUCTR2019-001983-31-GB
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| Associated Drug: |
Belapectin
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| Title: |
A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis. - NASH-RX
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Esophageal Varices in NASH Cirrhosis <br>MedDRA version: 20.0
Level: LLT
Classification code 10009214
Term: Cirrhosis of liver without mention of alcohol
System Organ Class: 100000004871
<br>MedDRA version: 21.1
Level: LLT
Classification code 10055489
Te
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| Interventions: |
<br>Product Name: Belapectin<br>Product Code: GR-MD-02<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: N.A.<br>CAS Number: 1980787-47-0<br>Current Sponsor code: GR-MD-02<br>Other descriptive name: Galactoarabino-rhamnogalacturonate<b
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| Outcome Measures: |
Main Objective: To evaluate the efficacy of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR MD 02) compared to placebo in preventing the development of esophageal varices.;Secondary Objective: To evaluate the effect of belapectin on composite clinical outcomes.;Primary end point(s): Proportion of patients in the belapectin treatment<br>groups who develop esophageal varices at<br>78 weeks (18 months) of treatment compared to<br>placebo;Timepoint(s) of evaluation of this end point: Phase 2b-Phase 3Secondary end point(s): Key Secondary Efficacy Endpoint<br>Incidence rate of patients in the belapectin<br>treatment groups, compared to placebo, who<br>develop any of the following: 1) varices<br>(esophageal or gastric) requiring treatment,<br>2) variceal bleed requiring hospitalization,<br>3) clinically significant ascites requiring<br>hospitalization, 4) spontaneous bacterial<br>peritonitis, 5) overt hepatic encephalopathy (West<br>Haven score =2 and requiring hospitalization),<br>6) mortality (all-cause), 7) liver transplant,<br>8) model for end-stage liver disease (MELD) score<br>=15;Timepoint(s) of evaluation of this end point: Phase 2b-Phase 3
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| Sponsor/Collaborators: |
Galectin Therapeutics Inc.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
395
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Seamless, Adaptive
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other:
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| Start Date: |
05/08/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
30 November 2020
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| Locations: |
United States;France;Mexico;Canada;Spain;Poland;Belgium;Australia;Israel;Germany;United Kingdom;Korea, Republic of
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001983-31
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