NL-OMON51229已完成3 期
Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD) - STAGED-EXT - LTS15823
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female adult with ADPKD who has completed the treatment period in
- •Stage 1 or Stage 2 of Study EFC15392.
- •- The patient has an eGFR >30 mL/min/1.73 m2:
- •a) measured at Visit 11 of the EFC15392 study for participant enrolled in the
- •LTS15823 study at the time of Visit 12 (Month 24; end-of treatment visit) of
- •the EFC15392 study.
- •b) measured at Screening visit for participant enrolled in the LTS15823 study
- •not concomitantly to the Visit 12 (Month 24; end-of treatment visit) of the
- •EFC15392 study.
- •- Contraceptive use by men and women should be consistent with local
- •regulations regarding the methods of contraception for those participating in
- •clinical studies.
- •a) Male participants must agree to practice true abstinence in line with their
- •preferred and usual lifestyle or to use double-contraceptive methods for the
- •entire duration of the study and for at least 90 days following their last dose
- •b) Female participants must have a negative urine pregnancy test at the
- •Baseline visit and agree to practice true abstinence in line with their
- •preferred and usual lifestyle or to use double contraceptive methods (including
- •a highly effective method of contraception) for the entire duration of the
- •study and for at least 6 weeks following their last dose of IMP.
- •- Capable of giving signed informed consent before performance of any study
- •related procedures not part of standard medical care.
- •- Able to read, comprehend, and respond to the study questionnaires.
排除标准
- •For participants who have lag phase between the end of the EFC15392 study and
- •Screening visit (Visit 0) in the LTS15823 study:
- •-The patient has a new clinically significant, uncontrolled medical condition
- •that, in the opinion of the Investigator, would put the safety of the patient
- •at risk through participation, or which would affect the efficacy or safety
- •analysis if the condition exacerbated during the study, or that may
- •significantly interfere with study compliance, including all prescribed
- •evaluations and follow-up activities.
- •-A history of drug abuse and/or alcohol abuse or alcohol dependence during the
- •lag phase between the end of the EFC15392 study and Screening visit (Visit 0)
- •in the LTS15823 study when applicable.
- •-Administration of tolvaptan or other polycystic kidney disease-modifying
- •agents (somatostatin analogues) within 3 months prior to the Screening visit
- •(Visit 0) in the LTS15823 study when applicable.
- •-The patient is currently receiving potentially cataractogenic medications,
- •including a chronic regimen (more frequently than every 2 weeks) of any route
- •of corticosteroids (including medium and high potency topical steroids), or any
- •medication that may cause cataract, according to the prescribing Information.
- •-The patient has received strong or moderate inducers or inhibitors of CYP3A4
- •within 14 days or 5 half lives, whichever is longer, prior to the Baseline
- •visit (including consumption of grapefruit-containing products within 72 hours
- •of starting venglustat administration).
- •-Participation in another investigational interventional study or use of IMP,
- •within 3 months or 5 half-lives, whichever is longer, before the Baseline visit
- •(Visit 1) except participation in the EFC15392 study when applicable.
- •-Liver enzymes (alanine aminotransferase /aspartate aminotransferase) or total
- •bilirubin >2 times the upper limit of normal unless the patient has the
- •diagnosis of Gilbert syndrome. Patients with the Gilbert syndrome should have
- •no additional symptoms or signs which suggest hepatobiliary disease and serum
- •total bilirubin level no more than 3 mg/dL (51 *mol/L) with conjugated
- •bilirubin less than 20% of the total bilirubin fraction.
- •For participants with or without lag phase between the end of EFC15392 study
- •and entry into LTS15823 study:
- •-The patient is pregnant or lactating.
- •-Presence of severe depression as measured by Beck Depression Inventory II >28
- •at Visit 1 (for participants enrolled in the LTS15823 study at the time of the
- •end of treatment visit of the EFC15392 study) or at Visit 0 (for participants
- •enrolled in the LTS15823 study after the end-of-treatment visit of the EFC15392
- •-Sensitivity to any of the study interventions, or components thereof, or drug
- •or other allergy that, in the opinion of the Investigator, contraindicates
- •participation in the study.
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