An Open Label Study of Oxabact® in patients with primary hyperoxaluria
Research type
Research Study
Full title
An open-label single-arm treatment extension study to evaluate the long- term efficacy and safety of Oxabact® for patients with primary hyperoxaluria who completed study OC5-DB-02
IRAS ID
260705
Contact name
Shabbir Moochhala
Contact email
Sponsor organisation
OxThera Intellectual Property AB
Eudract number
2018-003576-12
Duration of Study in the UK
3 years, 5 months, 2 days
Research summary
This study, (OCB-OL-02 ePHex Open Label Extension (OLE)) is an extension to a study currently ongoing (OCB-DB-02 ePHex) investigating a new medicine to potentially treat Primary Hyperoxaluria that is also known as PH. PH is a genetic (having to do with origin, birth) disease that causes the body to make too much of a substance called oxalate. PH can cause patients to have large amounts of oxalate in their blood and urine, which means that they are more likely to have calcium oxalate crystals in their body, especially in the kidneys. These stones cause damage to the affected organs and tissues. In the current study (OCB-DB-02) the patients are either on placebo or the the active drug Oxabact®. In this study, all patients will be given the active drug to evaluate the efficacy and safety of Oxabact® treatment for an additional two years. Subjects who consent to participate will, upon completion of (OCB-DB-02 ePHex), be directly transferred into this study.
At least, sixteen subjects, aged 2 years and over, will be included in the study in 8-10 sites in 7 countries, Germany, France, the United Kingdom, Belgium, Spain, the Netherlands, Tunisia and the United States.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0032
Date of REC Opinion
12 Apr 2019
REC opinion
Further Information Favourable Opinion