Hyperoxaluria, PrimaryPhase 3ePHex-OLENCT03938272
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
A Phase 3 study testing Oxabact OC5 - Oxalobacter formigenes Strain HC-1 in people with Hyperoxaluria, Primary, run by OxThera at 8 sites in 6 countries.
Trial summary
Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Hyperoxaluria, Primary
- What is being tested?
- Oxabact OC5 - Oxalobacter formigenes Strain HC-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 14 Mar 2019to 14 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Tunisia3 sites
Hédi Chaker University Hospital
Sfax, 3000
Sahloul University Hospital
Sousse, 4054
Charles Nicolle University Hospital
Tunis, 1008
United States1 site
Vanderbilt University Hospital
Nashville, Tennessee, 37232
About this study
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
Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
Read the 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).
- Conditions
- Hyperoxaluria, Primary
- Being tested
- Oxabact OC5 - Oxalobacter formigenes Strain HC-1
- Medical subject headings
- Hyperoxaluria, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxabact OC5 - Oxalobacter formigenes Strain HC-1Biological
Live, commensal bacteria
| Study group | Role | What they receive |
|---|---|---|
| Oxabact OC5 capsules | Experimental | Oxabact OC5 - Oxalobacter formigenes Strain HC-1 Receives: Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 104 weeks
Secondary outcomes (1)
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.
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start14 Mar 2019
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Why it stopped: Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperoxaluria, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label study in which all patients will receive Oxabact OC5
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- OxThera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gesa Schalk, MD, Principal investigator, KindernierenZentrum, Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938272
- Sponsor's protocol ID
- OC5-OL-02
- Acronym
- ePHex-OLE
- Status last verified
- Nov 2021
- First submitted
- 3 May 2019
- Last updated
- 8 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03938272
- Acronym / sponsor ID
- ePHex-OLE / OC5-OL-02
- Conditions
- Hyperoxaluria, Primary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- OxTheraIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 8 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label study in which all patients will receive Oxabact OC5
| Arm | Type | Receives |
|---|---|---|
| Oxabact OC5 capsules | Experimental | Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1Oxabact OC5 - Oxalobacter formigenes Strain HC-1 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxabact OC5 - Oxalobacter formigenes Strain HC-1Live, commensal bacteria | Biological | Oxabact OC5 capsules |
Primary outcome
Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment
Time frame: 104 weeks
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.
1 secondary outcome
Change From Baseline in Plasma Oxalate Concentration
Time frame: Up to 104 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gesa Schalk, MD principal investigator
KindernierenZentrum, Bonn, Germany
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxabact OC5 - Oxalobacter formigenes Strain HC-1 in people with Hyperoxaluria, Primary, run by OxThera at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Tunisia, United States, Belgium, Germany, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment (time frame: 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.