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

NCT ID: NCT03938272

Last Updated: 2021-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2021-07-14

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).

Conditions

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Hyperoxaluria, Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label study in which all patients will receive Oxabact OC5
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxabact OC5 capsules

Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Group Type EXPERIMENTAL

Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Intervention Type BIOLOGICAL

Live, commensal bacteria

Interventions

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Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Live, commensal bacteria

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OxThera

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gesa Schalk, MD

Role: PRINCIPAL_INVESTIGATOR

KindernierenZentrum, Bonn, Germany

Locations

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Vanderbilt University Hospital

Nashville, Tennessee, United States

Site Status

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Site Status

Kindernierenzentrum Bonn

Bonn, , Germany

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hédi Chaker University Hospital

Sfax, , Tunisia

Site Status

Sahloul University Hospital

Sousse, , Tunisia

Site Status

Charles Nicolle University Hospital

Tunis, , Tunisia

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United States Belgium Germany Spain Tunisia United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OC5-OL-02

Identifier Type: -

Identifier Source: org_study_id