EUCTR2014-001353-16-GB进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 121
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
- •1.Written informed consent
- •2. Men or women aged 18 years and older
- •3. Systemic sclerosis, as defined by ACR/EULAR 2013 criteria
- •4. dcSSc according to the LeRoy criteria, i.e. skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
- •5. Disease duration of = 18 months (defined as time from the first non-Raynaud’s phenomenon manifestation)
- •6. = 10 and = 22 mRSS units at the screening visit
- •7. FVC = 45% of predicted at screening
- •8. DLCO = 40% of predicted (hemoglobin-corrected) at screening
- •9. Negative serum pregnancy test in a woman of childbearing potential at the screening visit
- •10. Women of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception” is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies since signing of the informed consent form until 30 (+5) days after the last study drug administration.
- •Are the trial subjects under 18? no
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Limited cutaneous SSc at screening
- •2. Major surgery (including joint surgery) within 8 weeks prior to screening
- •3. Hepatic insufficiency classified as Child-Pugh C
- •Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial
- •4. Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73m2 will be undergo additional monitoring of renal function
- •- Because the MDRD formula is thought to cause significant bias for Japanese patients, the equation for Japanese patients is: 194 x serum creatinine (mg/dL) -1.094 x Age -0.287 x 0.739 (if female).
- •5. Any prior history of renal crisis
- •6. Sitting SBP < 95 mmHg at the screening visit
- •7. Sitting heart rate < 50 beats per minute (BPM) at the screening visit
- •8. Left ventricular ejection fraction < 40% prior to screening
- •9. Any form of pulmonary hypertension as determined by right heart catheterisation
- •10. Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening
- •11. Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
- •12. Any history of bronchial artery embolisation or massive haemoptysis is defined as acute bleeding >240 mL in a 24 hour period or recurrent bleeding >100 mL/day over consecutive days)
- •13. Not permitted prior and concomitant medication (updated)
- •14. pregnant or breast feeding women
- •15. Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
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