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 - Open label extension study to verify long term safety of OxabactTM , the Phoenix II study

OxThera, Inc.0 个研究点目标入组 0 人开始时间: 2008年2月15日最近更新: 2019年11月25日

研究概览

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•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

•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

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