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NCT03116685 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
A Phase 3 study, sponsored by OxThera.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT03116685: Completed Phase 3 study, sponsored by OxThera.
NCT03116685 is a Phase 3 study that has completed, run by OxThera. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03116685, a Phase 3 study, has completed, sponsored by OxThera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of OC5 in patients with PH.
Primary Outcome
Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter
Interventions
- OTHER Placebo
- BIOLOGICAL Oxabact OC5 - Oxalobacter formigenes HC-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2021-04-15 |
| Phase | Phase 3 |
What the finished NCT03116685 record still lists
NCT03116685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03116685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03116685 about?
NCT03116685 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria". This study will evaluate the efficacy and safety of OC5 in patients with PH.
What is the current status of trial NCT03116685?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2018-01-09. Estimated completion is 2021-04-15.
What interventions are being tested in trial NCT03116685?
The interventions under investigation include: Placebo (OTHER), Oxabact OC5 - Oxalobacter formigenes HC-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03116685?
This trial is sponsored by OxThera, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03116685's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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