primary hyperoxaluria MedDRA version: 9.1 Level: LLT Classification code 10020703 Term: Hyperoxaluria
Conditions
Interventions
Product Name: Oxabact (tm) - Oxalobacter formigenes strain HC1
Product Code: OC3
Pharmaceutical Form: Gastro-resistant capsule, hard
Current Sponsor cod
Sponsors
OxThera, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject (or legally acceptable representative) must give informed consent (and assent for subjects = 12 years or country specific age as appropriate). For subjects less than 18 years of age, parent or guardian will provide informed consent and the subject will provide witnessed verbal assent 2. All subjects completing the qualifying study (OC3-DB-01 : EudraCT 2007-002328-14) will be eligible for open-label extension study 3. Subjects receiving pyridoxine during the qualifying study (OC3-DB-01) must be willing to remain on the stable dose at entry and during the OL study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom by the sexual partner, or sterile sexual partner) and must agree to continue using such precautions during the OL extension study. 2. Positive serum pregnancy test 3. Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator, is indicative of a disease that would compromise the safety of the subject 4. Subjects not willing to forego other forms of investigational treatment during the OL study 5. Chronic immune suppressive therapy including prednisone at doses greater than 10 mg daily for more than 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of OxabactTM with continued exposure;Secondary Objective: To obtain additional efficacy data with up to 48 weeks continuous exposure to Oxabact™.; Primary end point(s): Safety • Frequency of AEs and SAEs • Abnormal Laboratory Values • Clinically relevant changes in Physical Exams and Vital Signs | — |
Countries
France, Germany, Netherlands, United Kingdom
Outcome results
None listed