An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study

Phase 3

• Conditions: Primary Hyperoxaluria (PH); 10021605; 10038430

• Registration Number: NL-OMON31883
• Lead Sponsor: OxThera Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 4

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. (This is the text in the protocol, in the Netherlands no signature from subjects younger than 12 is needed, see text D4b.);2. All subjects completing the qualifying study (OC3-DB-01) 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>* Frequency of AEs and SAEs<br /><br>* Abnormal Laboratory Values<br /><br>* Clinically relevant changes in Physical Exams and Vital Signs</p><br>