EUCTR2017-001764-37-GB进行中（未招募）1 期
A PHASE II, OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA30044 TO EVALUATE THE LONG-TERMSAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •- Age 18-76 years
- •- Completion of Study GA30044 up to 48 weeks
- •- Acceptable safety and tolerability during Study GA30044 as determined by the investigator
- •- Women of childbearing potential must have a negative urine pregnancy test at baseline
- •- For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 60 days after the last dose of study drug
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm resulting in a failure rate of < 1% per year during the treatment period and for at least 120 days (4 months) after the last dose of study treatment
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Met protocol-defined treatment-stopping criteria during Study GA30044
- •- An adverse event in Study GA30044 that required permanent discontinuation of study drug
- •- During Study GA30044, treatment with any therapy that is prohibited in this study
- •- In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the patient at undue risk from a safety perspective
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of study drug
- •- Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator in consultation with the Medical Monitor
- •- Any major episode of infection requiring hospitalization or treatment with IV antibiotics within the last 4 weeks of study GA30044
- •- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
- •- Patients who experienced a de novo or reactivated serious viral infection, such as hepatitis B virus or hepatitis C virus (HCV) during Study GA30044
- •- Patients who developed a malignancy (with the exception of non-serious local and resectable basal or squamous cell carcinoma of the skin) during the Phase II Study GA30044
- •- 12-lead ECG at the Week 48 visit of Study GA30044 that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results
- •- Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT, as determined by the investigator
- •- Estimated glomerular-filtration rate (based on the 4-variable Modification of Diet in Renal Disease equation) < 30 mL/min or on chronic renal replacement therapy
- •- Laboratory values from the Week 44 visit of Study GA30044 (which may be repeated once at a later unscheduled visit, if necessary) that meet the following criteria: AST or ALT > 1.5 × ULN (unless due to known autoimmune hepatitis, Total bilirubin > 1.2 ULN, Amylase or lipase > 2 × ULN, Hemoglobin < 7 g/dL, ANC < 1.5 × 109/L, Absolute lymphocyte count (ALC) < 0.5 × 109/L, Platelet count < 50,000/µL.
研究者
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