EUCTR2017-002067-18-BE进行中（未招募）1 期
A multicenter, randomised, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Advicenne
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for inclusion into the study, the subjects must fulfil all of
- •the following criteria:
- •1. Patient who has a diagnosis of cystinuria based on medical diagnosis
- •(at least one previous or current episode of calculus of cystine, and/or
- •one previous or current episode of cystine crystalluria) or on genetic
- •diagnosis (only for patients enrolled in B13CS study).
- •2. Patient treated with an alkalising treatment at a well-adapted dose
- •(defined as a daily dose deemed by the investigator aiming to maintain
- •overtime urinary pH value = 7.0 and/or compatible with an acceptable
- •safety profile and/or patient's constraints or compliance).
- •3. Patient who, when treated with a second line therapy (chelator
- •agent), presents a disease status enabling interruption of the chelator
- •agent during the course of the B12CS-B13CS research.
- •4. Patient male or female, including child aged between 6 months and
- •17 years old and adult aged = 18 years old up to 70 years old.
- •5. For patient with mild to moderate renal impairment (45= estimated
- •glomerular filtration rate (eGFR) <60 mL/min/1.73 m², according to
- •Schwartz formula for children and CKD-EPI for adults): normal kalaemia
- •(< 5.0 mmol/L), AND a body mass index (BMI) < 30 Kg/m².
- •6. Women of childbearing potential (WOCBP) (defined by the Clinical
- •Trial Facilitation Group (CTFG) as woman fertile, following menarche
- •until becoming post-menopausal unless permanently sterile*) using a
- •highly effective birth control method** until the end of study (i.e. until
- •36 hours after the last dose of IMP) and having a serum negative
- •pregnancy test at the screening, or a woman postmenopausal or a
- •woman surgically sterilised
- •7. Patient and/or parents or legal representative(s) who is(are) willing
- •and able to participate in the study, to understand and to comply with
- •study procedures for the entire length of the study.
- •8. Patient or parents or legal representative(s) who has/have provided
- •a signed written informed consent.
- •9. Patient of =17 years of age for whom the assent has been collected
- •or has been tried to be collected.
- •10. Patient who is affiliated to a social health insurance system and/or
- •in compliance with the recommendations of the national law in force
- •relating to biomedical research.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 78
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •To be eligible for inclusion into the study, the subjects must not meet
- •any of the following criteria:
- •1. Patient treated with the second line therapy and who cannot stop
- •cystine chelating agents (sulfhydryl compounds) during the B12CSB13CS
- •2. Patient who presents kalaemia > 5.0 mmol/L.
- •3. Patient who presents a renal impairment as following:
- •- severe renal impairment (eGFR < 45 mL/min/1.73 m2 according to
- •Schwartz formula for children and CKD-EPI for adults),
- •XML File Identifier: 5req015GVN6Ni+SmfMfA1eCEbog=
- •- mild to moderate renal impairment not stabilised (45 = eGFR < 60
- •mL/min/1.73 m2, according to Schwartz formula for children and CKDEPI
- •for adults), AND a BMI =.30 Kg/m²
- •4. Patient who presents - barring the study disease - any previous or
- •concurrent medical condition or any laboratory or clinical findings or any
- •other condition that in the opinion of the investigator would be
- •negatively affected by the study medication or that would affect the
- •study medication or that precludes participation, e.g. uncontrolled
- •diabetes mellitus, adrenal insufficiency, cardiac impairment, repeated
- •infections, metabolic alkalosis, chronic diarrhoea.
- •5. Female patient who is pregnant or breast-feeding.
- •6. Patient who cannot stop potassium sparing diuretics (e.g.
- •antagonists of aldosterone as such spironolactone, canrenoate and
- •eplerenone, amiloride, triamterene), angiotensin converting enzyme
- •inhibitors, angiotensin II receptor antagonists, tacrolimus, ciclosporine,
- •potassium desodic salts, nonsteroidal anti-inflammatory drugs and
- •cardiac glycosides.
- •7. Patient who received any medication that could interfere with the
- •study treatment within 4 weeks before the inclusion in the study,
- •including angiotensin converting enzyme inhibitors, angiotensin II
- •receptor antagonists, tacrolimus, potassium desodic salts, antibiotics
- •limited to sulfamides, quinolones and azithromycine.
- •8. Patient who received potassium sparing diuretics 6 weeks before the
- •inclusion in the study.
- •9. Patient who presents contra indications to the administration of the
- •study treatment such like known allergic reactions or hypersensitivity to
- •the active pharmaceutical ingredients or other excipients of the
- •formulations of the study treatment (such as lactose), history of difficult
- •access to the oral administration route and/or conditions that may
- •hamper compliance and/or absorption of the study treatment (e.g. any
- •difficulty of swallowing, mal-absorption, delayed gastric emptying,
- •oesophageal compression, intestinal obstruction or other chronic gastrointestinal
- •10. Patient who is admitted to hospital in emergency settings.
- •11. Patient who participated in a clinical trial within the last 3 months
- •before enrolment.
- •12. Patient who is at risk of non-compliance in the judgment of the
- •investigator.
- •13. Patient who could present any other condition, which in the opinion
- •of the investigator, would preclude participation in the study.
- •14. Patient who cannot be contacted in case of emergency.
- •15. Patient under any administrative or legal supervision.
研究者
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