| Trial ID: | L0394 |
| Source ID: | EUCTR2019-001983-31-ES
|
| Associated Drug: |
Belapectin
|
| 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
|
| Acronym: |
--
|
| Status: |
Authorised
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| 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
|
| 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
|
| 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 groups who develop esophageal varices at 78 weeks (18 months) of treatment compared to placebo;Timepoint(s) of evaluation of this end point: Phase 2b-Phase 3Secondary end point(s): Key Secondary Efficacy Endpoint Incidence rate of patients in the belapectin<br>treatment groups, compared to placebo, who develop any of the following: <br>1) varices (esophageal or gastric) requiring treatment,<br>2) variceal bleed requiring hospitalization,<br>3) clinically significant ascites requiring hospitalization, <br>4) spontaneous bacterial peritonitis,<br>5) overt hepatic encephalopathy (West Haven score =2 and requiring hospitalization),<br>6) mortality (all-cause), <br>7) liver transplant,<br>8) model for end-stage liver disease (MELD) score =15;Timepoint(s) of evaluation of this end point: Phase 2b-Phase 3
|
| Sponsor/Collaborators: |
Galectin Therapeutics Inc.
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
395
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: Seamless, Adaptive<br>If controlled, specify comparator, Other Medicinial Prod
|
| Start Date: |
17/02/2021
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 June 2021
|
| Locations: |
France;United States;Mexico;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Korea, Republic of
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001983-31
|
