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

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

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

Study Overview

• Status: Terminated
• Conditions: Hyperoxaluria, Primary
• Intervention / Treatment: Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1

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).

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium
    • Centre Hospitalier Universitaire de Liege
• Germany
  • Bonn, Germany, 53127
    • Kindernierenzentrum Bonn
• Spain
  • Barcelona, Spain
    • Hospital Vall d'Hebron
• Tunisia
  • Sfax, Tunisia, 3000
    • Hédi Chaker University Hospital
  • Sousse, Tunisia, 4054
    • Sahloul University Hospital
  • Tunis, Tunisia, 1008
    • Charles Nicolle University Hospital
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed informed consent (as applicable for the age of the subject).
2. Participation in and completion of study OC5-DB-02.
3. 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:

1. Inability to swallow size 4 capsules.
2. Use of antibiotics to which O. formigenes is sensitive.
3. Current treatment with a separate ascorbic acid preparation.
4. Pregnant or lactating women (or women who are planning to become pregnant).
5. Women of childbearing potential who are not using adequate contraceptive precautions.
6. 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).
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxabact OC5 capsules; Oxabact OC5 - Oxalobacter formigenes Strain HC-1	Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1; Live, commensal bacteria

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OxThera
• Investigators: Principal Investigator: Gesa Schalk, MD, KindernierenZentrum, Bonn, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Hyperoxaluria; Hyperoxaluria, Primary
• Other Study ID Numbers: OC5-OL-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No