Autopsy report · NCT04365868

Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

“Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 4 years 10 months before it stopped.
• 357 participants enrolled.
• Results were posted on the registry 1 year 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

Galectin Therapeutics Inc.

Sponsor type

Industry

Conditions

Prevention of Esophageal Varices; NASH - Nonalcoholic Steatohepatitis; Cirrhosis

Interventions

belapectin; Placebo

Participants

357

Sites

156

Countries

Argentina, Australia, Belgium, Canada, Chile, France, Germany, Israel, Mexico, Poland, Puerto Rico, South Korea and more

Trials that died the same way

• Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)
  “Stage 1 interim analysis of efficacy met the criteria for early trial termination (futility). The trial was terminated at Stage 1; did not proceed to Stage 2.” (63% match in meaning)
• Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
  “The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.” (62% match in meaning)
• Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
  “Due to study design (and toxicity), this trial closed to accrual prior to opening the phase II portion.” (60% match in meaning)
• A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
  “Due to safety findings in ongoing Phase 2 trials.” (60% match in meaning)
• Nelfinavir in Systemic Lupus Erythematosus
  “Stage 1 terminated 6/1/18 prior to completion of Stage 1 due to low enrollment and efficacy” (59% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.