Hyperoxaluria, Primary Clinical Trial
— ePHex-OLEOfficial 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
| Verified date | November 2021 |
| Source | OxThera |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | July 14, 2021 |
| Est. primary completion date | July 14, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Centre Hospitalier Universitaire de Liège | Liège | |
| Germany | Kindernierenzentrum Bonn | Bonn | |
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Tunisia | Hédi Chaker University Hospital | Sfax | |
| Tunisia | Sahloul University Hospital | Sousse | |
| Tunisia | Charles Nicolle University Hospital | Tunis | |
| United Kingdom | Royal Free Hospital | London | |
| United States | Vanderbilt University Hospital | Nashville | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| OxThera |
United States, Belgium, Germany, Spain, Tunisia, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Up to 104 weeks |