CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
Mangoraldrug
Likely dose
Mangoral 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04119843
NCT04119843Phase 3Completed
CompareCT.gov

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Ascelia Pharma AB·interventional·Posted Oct 8, 2019·Updated Feb 6, 2025

In Brief

A Phase 3 clinical trial evaluating Mangoral for Known or Suspected Focal Liver Lesions and Severe Renal Impairment. Completed, enrolled 87 participants across 60 sites in 10 countries.

Detailed Summary

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnown or Suspected Focal Liver Lesions, Severe Renal Impairment
CountriesArgentina, Colombia, Germany, Italy, Mexico, Poland, Russia, Sweden, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 8, 2019
Enrollment StartFeb 19, 2020
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

Interventions

Mangoraldrug

800 mg manganese chloride \[II\] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3