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

Study Overview
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Brief Summary
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Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria

Detailed Description
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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).

Official Title
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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

Conditions
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Hyperoxaluria, Primary

Intervention / Treatment
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* Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label study in which all patients will receive Oxabact OC5
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxabact OC5 capsules<br>Oxabact OC5 - Oxalobacter formigenes Strain HC-1 | Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1<br>* Live, commensal bacteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment | 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. | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plasma Oxalate Concentration | 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. | Up to 104 weeks |