A Phase 3 interventional study of Oxabact OC5 - Oxalobacter formigenes Strain HC-1 in Hyperoxaluria, Primary, sponsored by OxThera. Terminated at 8 sites in 6 countries. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2021-12-08.
Sponsored by OxThera · Phase 3, Interventional, and Treatment
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).
42 studies on the registry are indexed under Hyperoxaluria, Primary; 11 are open to participants now.
This study's enrollment of 22 is close to the median of 24 across 26 interventional studies indexed under Hyperoxaluria, Primary.
Browse Hyperoxaluria, Primary studies →OxThera is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Biological: Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Live, commensal bacteria
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
| Milestone | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex |
|---|---|---|
| Started | 11 | 11 |
| Completed | 0 | 1 |
| Not completed | 11 | 10 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Study termination by sponsor | 10 | 8 |
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.
| mL/min/1.73 m2 | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex |
|---|---|---|
| Baseline value | 74.193 ± 9.952 | 58.617 ± 20.858 |
| Month 2 | -1.568 ± 3.129 | -1.218 ± 5.255 |
| Month 4 | -3.246 ± 8.158 | -2.932 ± 9.889 |
| Month 6 | -9.547 ± 14.017 | 3.083 ± 8.614 |
| Month 8 | -9.293 ± 13.633 | 7.825 ± 4.264 |
| Month 10 | 1.798 ± 3.312 | 4.530 ± 0.665 |
| Month 12 | -5.840 ± 11.672 | -0.994 ± 6.778 |
| Month 15 | -5.862 ± 8.954 | 2.190 ± 0.764 |
| Month 18 | — | 2.785 ± 0.516 |
| Month 21 | -12.193 | -3.340 |
| Month 24 | — | -7.110 |
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.
| μmol/L | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex |
|---|---|---|
| Baseline value | 15.9 ± 6.6 | 18.1 ± 7.3 |
| Month 2 Change from baseline | 2.1 ± 7.2 | 1.1 ± 7.0 |
| Month 4 Change from baseline | 4.0 ± 8.5 | 1.3 ± 6.1 |
| Month 6 Change from baseline | 6.1 ± 10.0 | 2.3 ± 4.8 |
| Month 8 Change from baseline | 13.8 ± 14.6 | -5.5 ± 0.7 |
| Month 10 Change from baseline | 5.4 ± 6.0 | -8.5 ± 2.1 |
| Month 12 Change from baseline | 14.0 ± 15.7 | 0.4 ± 5.7 |
| Month 15 Change from baseline | 12.3 ± 9.6 | 4.0 ± 8.5 |
| Month 18 Change from baseline | — | 20.5 ± 24.7 |
| Month 21 Change from baseline | -2.3 | 4.0 |
| Month 24 Change from baseline | — | -7.0 |
Collected over Open label extension up to 24 months of treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxabact OC5 Capsules; OC5 in ePHex | 0/11 (0%) | 3/11 (27.3%) | 7/11 (63.6%) |
| Oxabact OC5 Capsules; Placeob in ePHex | 0/11 (0%) | 1/11 (9.1%) | 8/11 (72.7%) |
| Event | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placeob in ePHex |
|---|---|---|
| NephrolithiasisRenal and urinary disorders | 1/11 | 1/11 |
| Renal colicRenal and urinary disorders | 0/11 | 1/11 |
| PyrexiaGeneral disorders | 1/11 | 0/11 |
| PyelonephritisInfections and infestations | 1/11 | 0/11 |
| Pyelonephritis acuteInfections and infestations | 1/11 | 0/11 |
| Burns second degreeInjury, poisoning and procedural complications | 1/11 | 0/11 |
| Event | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placeob in ePHex |
|---|---|---|
| PyrexiaGeneral disorders | 4/11 | 0/11 |
| COVID-19Infections and infestations | 0/11 | 3/11 |
| HeadacheNervous system disorders | 1/11 | 3/11 |
| Urinary tract infectionInfections and infestations | 2/11 | 1/11 |
| PharyngotonsillitisInfections and infestations | 2/11 | 0/11 |
| Abdominal pain upperGastrointestinal disorders | 2/11 | 0/11 |
| NephrolithiasisRenal and urinary disorders | 2/11 | 2/11 |
| Calculus urinaryRenal and urinary disorders | 0/11 | 2/11 |
| Flank painMusculoskeletal and connective tissue disorders | 1/11 | 2/11 |
| Eosinophil count increasedInvestigations | 2/11 | 0/11 |
| Age, Categorical(Participants) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| <=18 years | 7 | 8 | 15 |
| Between 18 and 65 years | 4 | 3 | 7 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| Mean | 14.0 ± 6.9 | 17.1 ± 14.2 | 15.5 ± 11.0 |
| Sex: Female, Male(Participants) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 3 | 7 | 10 |
| Race (NIH/OMB)(Participants) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 10 | 11 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| Belgium | 0 | 2 | 2 |
| United Kingdom | 1 | 1 | 2 |
| Germany | 2 | 4 | 6 |
| Spain | 5 | 2 | 7 |
| Tunisia | 3 | 1 | 4 |
| United States | 0 | 1 | 1 |
| Primary hyperoxaluria diagnosis(Participants) | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|
| PH Type I | 11 | 10 | 21 |
| PH Type II | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2019 to primary completion in Jul 2021, 28 months.
Results were first posted in Dec 2021, 4 months after primary completion.
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This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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