CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Oxabact OC5 - Oxalobacter formigenes HC-1 +1 morebiological
Likely dose
Not stated in 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/NCT03116685
NCT03116685Phase 3Completed
CompareCT.gov

A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

OxThera·interventional·Posted Apr 17, 2017·Updated Dec 10, 2021

In Brief

A Phase 3 clinical trial evaluating Oxabact OC5 - Oxalobacter formigenes HC-1 and Placebo for Primary Hyperoxaluria. Completed, enrolled 25 participants across 10 sites in 7 countries.

Detailed Summary

This study will evaluate the efficacy and safety of OC5 in patients with PH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hyperoxaluria
CountriesBelgium, France, Germany, Spain, Tunisia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 17, 2017
Enrollment StartJan 9, 2018
Primary CompletionApr 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.2 years ago

Interventions

Oxabact OC5 - Oxalobacter formigenes HC-1biological

Active study drug

Placeboother

Placebo