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Phase 2/3 randomized placebo-controlled study of Oxabact in primary hyperoxaluria
2009-015817-31Phase 3Completed
- Sponsor
- OxThera AB
- Start
- Sep 2009
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in Primary hyperoxaluria (PH) and hyperoxaluria comparing Oxabact with Placebo (2 arms). Primary endpoints: Primary: Percentage change in urinary oxalate (oxalate/creatinine ratio) from baseline to week 24 and Primary safety: Safety of Oxabact over 24 weeks. Started Sep 2009; status: completed.
02
Drugs
oxalobacter formigenes
03
Conditions
Primary hyperoxaluria (PH)hyperoxaluria
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