Clinical trial NCT03938272: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperoxaluria, Primary
Lead sponsor: OxThera
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label study in which all patients will receive Oxabact OC5
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment
timeFrame: 104 weeks
Secondary outcomes:
measure: Change From Baseline in Plasma Oxalate Concentration
timeFrame: Up to 104 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Hospital
state: Tennessee
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Bonn
country: Germany
facility: Kindernierenzentrum Bonn
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Sfax
country: Tunisia
facility: Hédi Chaker University Hospital
city: Sousse
country: Tunisia
facility: Sahloul University Hospital
city: Tunis
country: Tunisia
facility: Charles Nicolle University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: KindernierenZentrum, Bonn, Germany
name: Gesa Schalk, MD
role: PRINCIPAL_INVESTIGATOR
References: