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An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

NCT03938272 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-12-08

Study results available
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Summary

Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria

Conditions

  • Hyperoxaluria, Primary

Interventions

BIOLOGICAL

Oxabact OC5 - Oxalobacter formigenes Strain HC-1

Live, commensal bacteria

Sponsors & Collaborators

  • OxThera

    lead INDUSTRY

Principal Investigators

  • Gesa Schalk, MD · KindernierenZentrum, Bonn, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2021-07-14
Completion
2021-07-14
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Germany
  • Spain
  • Tunisia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03938272 on ClinicalTrials.gov