Trials / Completed
CompletedNCT03116685
A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- OxThera · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of OC5 in patients with PH.
Detailed description
To evaluate the efficacy of Oxabact following 52 weeks treatment in subjects with maintained kidney function, but below the lower limit of the normal range (estimated glomerular filtration rate \[eGFR\] \< 90 ml/min/1.73 m2) and a total plasma oxalate (Pox) concentration ≥ 10 μmol/L. Parameters to be evaluated include the ability to stabilise/reduce Pox concentration, to stabilise/improve kidney function and to reduce oxalate deposits in primary hyperoxaluria (PH) subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oxabact OC5 - Oxalobacter formigenes HC-1 | Active study drug |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2018-01-09
- Primary completion
- 2021-04-15
- Completion
- 2021-04-15
- First posted
- 2017-04-17
- Last updated
- 2021-12-10
- Results posted
- 2021-12-09
Locations
10 sites across 7 countries: United States, Belgium, France, Germany, Spain, Tunisia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03116685. Inclusion in this directory is not an endorsement.