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

Phase 3

Terminated

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent (as applicable for the age of the subject).
Participation in and completion of study OC5-DB-02.
Subjects who had received vitamin B6 during OC5-DB-02 study should maintain a stable dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria

Inability to swallow size 4 capsules.
Use of antibiotics to which O. formigenes is sensitive.
Current treatment with a separate ascorbic acid preparation.
Pregnant or lactating women (or women who are planning to become pregnant).
Women of childbearing potential who are not using adequate contraceptive precautions.
Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal GI function).
Participation in any interventional study of another investigational product, biologic, device, or other agent or not willing to forego other forms of investigational treatment during this study.

Arm && Interventions

Group	Intervention	Description
Oxabact OC5 capsules	Oxabact OC5 - Oxalobacter formigenes Strain HC-1	Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment	104 weeks	Change in eGFR measured as mL/min/1.73m2. Baseline values are from the period before treatment with Oxabact. For the patients treated with Oxabact in the double-blind study, baseline is prior to treatment in that study. For patients who were treated with placebo in the double-blind study, baseline values are from the extension study, which was 48 to 52 weeks in the double-blind study.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Plasma Oxalate Concentration	Up to 104 weeks	Change in eGFR measured as mL/min/1.73m2. Baseline values are from the period before treatment with Oxabact. For the patients treated with Oxabact in the double-blind study, baseline is prior to treatment in that study. For patients who were treated with placebo in the double-blind study, baseline values are from the extension study, which was 48 to 52 weeks in the double-blind study.

Locations (8): Sahloul University Hospital
🇹🇳
Sousse, Tunisia
Kindernierenzentrum Bonn
🇩🇪
Bonn, Germany
Hédi Chaker University Hospital
🇹🇳
Sfax, Tunisia
Royal Free Hospital
🇬🇧
London, United Kingdom
Centre Hospitalier Universitaire de Liège
🇧🇪
Liège, Belgium
Hospital Vall d'Hebron
🇪🇸
Barcelona, Spain
Charles Nicolle University Hospital
🇹🇳
Tunis, Tunisia
Vanderbilt University Hospital
🇺🇸
Nashville, Tennessee, United States