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

Primary Purpose

Hyperoxaluria, Primary

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Sponsored by
OxThera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperoxaluria, Primary

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Hospital
  • Centre Hospitalier Universitaire de Liège
  • Kindernierenzentrum Bonn
  • Hospital Vall d'Hebron
  • Hédi Chaker University Hospital
  • Sahloul University Hospital
  • Charles Nicolle University Hospital
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxabact OC5 capsules

Arm Description

Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 3, 2019
Last Updated
November 11, 2021
Sponsor
OxThera
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1. Study Identification

Unique Protocol Identification Number
NCT03938272
Brief Title
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Acronym
ePHex-OLE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OxThera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperoxaluria, Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Open-label study in which all patients will receive Oxabact OC5
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxabact OC5 capsules
Arm Type
Experimental
Arm Description
Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Intervention Type
Biological
Intervention Name(s)
Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Intervention Description
Live, commensal bacteria
Primary Outcome Measure Information:
Title
Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment
Description
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.
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Plasma Oxalate Concentration
Description
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.
Time Frame
Up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gesa Schalk, MD
Organizational Affiliation
KindernierenZentrum, Bonn, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
Country
Belgium
Facility Name
Kindernierenzentrum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Hospital Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hédi Chaker University Hospital
City
Sfax
ZIP/Postal Code
3000
Country
Tunisia
Facility Name
Sahloul University Hospital
City
Sousse
ZIP/Postal Code
4054
Country
Tunisia
Facility Name
Charles Nicolle University Hospital
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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