Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Live, commensal bacteria
Vanderbilt University Hospital
Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Kindernierenzentrum Bonn
Bonn, Germany
Hospital Vall d'Hebron
Barcelona, Spain
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.
Time frame: 104 weeks
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.
Time frame: Up to 104 weeks
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Hédi Chaker University Hospital
Sfax, Tunisia
Sahloul University Hospital
Sousse, Tunisia
Charles Nicolle University Hospital
Tunis, Tunisia
Royal Free Hospital
London, United Kingdom