NCT03938272

An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

An Open-label Single-arm Treatment Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact for Patients With Primary Hyperoxaluria Who Completed Study OC5-DB-02

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: OxThera · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria

Detailed description

OC5-OL-02 (ePHex-OLE) is a 2 year, open-label, extension study to evaluate the long-term efficacy and safety of Oxabact OC5 for patients with primary hyperoxaluria who completed treatment in the parent double-blind, placebo-controlled study OC5-DB-02 (ePHex).

Conditions

• Hyperoxaluria, Primary

Interventions

Type	Name	Description
BIOLOGICAL	Oxabact OC5 - Oxalobacter formigenes Strain HC-1	Live, commensal bacteria

Timeline

• Start date: 2019-03-14
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2019-05-06
• Last updated: 2021-12-08
• Results posted: 2021-12-08

Locations

8 sites across 6 countries: United States, Belgium, Germany, Spain, Tunisia, United Kingdom

Regulatory

• FDA-regulated drug study