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AvailableNCT06931834

Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease

Expanded Access Treatment Protocol for R007 (Probucol) Tablets in Adults With Genetically-Confirmed Mitochondrial Disease and Chronic Kidney Disease (Intermediate-Size Patient Population)

Status
Available
Phase
Study type
Expanded Access
Enrollment
Sponsor
RiboNova Inc. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this expanded access program is to enable access to R007 (probucol) tablets for the compassionate treatment of adults with mitochondrial disease who also have chronic kidney disease.

Detailed description

The protocol for this expanded access program provides for the compassionate treatment with R007 (probucol) tablets of adults who (i) have serious or life-threatening mitochondrial disease and also have chronic kidney disease stages 3 or 4, (ii) do not have access to a satisfactory alternative therapy to treat their condition, and (iii) are not able to enroll in a clinical trial.

Conditions

Interventions

TypeNameDescription
DRUGProbucolProbucol 250 mg tablets orally up to a daily dose of 1,000 mg

Timeline

First posted
2025-04-17
Last updated
2025-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06931834. Inclusion in this directory is not an endorsement.

Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease (NCT06931834) · Clinical Trials Directory