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A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

NCT03116685 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-12-10

Study results available
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Summary

This study will evaluate the efficacy and safety of OC5 in patients with PH.

Conditions

  • Primary Hyperoxaluria

Interventions

BIOLOGICAL

Oxabact OC5 - Oxalobacter formigenes HC-1

Active study drug

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • OxThera

    lead INDUSTRY

Principal Investigators

  • Gesa Schalk, MD · KindernierenZentrum, Bonn, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2021-04-15
Completion
2021-04-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • 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 NCT03116685 on ClinicalTrials.gov