MedTrace Logo

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria

NCT02012985 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-10-16

No results posted yet for this study

Summary

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

Conditions

  • Primary Hyperoxaluria

Interventions

BIOLOGICAL

Oxabact OC5 capsules

The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.

DRUG

Placebo capsules

An enteric-coated placebo capsule manufactured to mimic the OC5 capsule. The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks.

Sponsors & Collaborators

  • FP7-SME-2013 Research for the benefit of SMEs program

    collaborator UNKNOWN

  • OxThera

    lead INDUSTRY

Principal Investigators

  • Bernd Hoppe, MD PhD · Universitätsklinikum Bonn, Dept of Paediatric Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

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 NCT02012985 on ClinicalTrials.gov