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

NCT03938272 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: OC5-OL-02
• Study Type: interventional
• Target: 22
• Locations: 6 countries
• Sites: 8

Brief Summary

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

Conditions

Hyperoxaluria, Primary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Plasma Oxalate Concentration

  Up to 104 weeks

Study Arms (1)

Oxabact OC5 capsules

EXPERIMENTAL

Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Interventions

Oxabact OC5 - Oxalobacter formigenes Strain HC-1 BIOLOGICAL

Live, commensal bacteria

Oxabact OC5 capsules

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OxThera: lead

Study Sites (8)

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Location

Kindernierenzentrum Bonn

Bonn, 53127, Germany

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hédi Chaker University Hospital

Sfax, 3000, Tunisia

Location

Sahloul University Hospital

Sousse, 4054, Tunisia

Location

Charles Nicolle University Hospital

Tunis, 1008, Tunisia

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hyperoxaluria, Primary

Condition Hierarchy (Ancestors)

Hyperoxaluria; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: OxThera

elisabeth.lindner@oxthera.com

0046 86600223

Study Officials

• Gesa Schalk, MD

  KindernierenZentrum, Bonn, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label study in which all patients will receive Oxabact OC5

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: March 14, 2019
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: December 8, 2021
• Results First Posted: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); TU (3); DE (1); US (1); GB (1); BE (1)