EUCTR2020-003745-11-IT进行中（未招募）1 期
An open label, single arm, extension trial to examine long-term safety of BI425809 once daily in patients with schizophrenia who have completedprevious BI 425809 Phase III trials.(CONNEX-X) -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 1,401 人开始时间: 2022年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,401
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. Signed and dated written informed consent in accordance with ICH
- •Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and
- •local legislation prior to admission to the trial (Visit 1).
- •2. Clinically stable outpatients who have been diagnosed with
- •schizophrenia (as per Diagnostic and Statistical Manual of Mental
- •Disorders, 5th edition (DSM-5)).
- •3. Patients, who completed 26 weeks of treatment in the parent trial,
- •must enter the extension trial within:
- •Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013.
- •At the end of safety follow up in 1346-0012.
- •4. Women of childbearning potential (WOCBP) must be ready and able
- •to use highly effective methods of birth control per Non-Clinical Safety
- •Studies for the Conduct of Human Clinical Trials and Marketing
- •Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low
- •failure rate of less than 1% per year when used consistently and
- •correctly. Such methods should be used throughout the trial, and for a
- •period of at least 35 days after last trial drug intake, and the patient
- •must agree to periodic pregnancy testing during participation in the trial.
- •5. Have a study partner, defined as any person capable of understanding
- •trial related procedures, with a minimum of 8th grade level of
- •education, who knows the patient well, has been capable of interacting with the patient on regular basis (at least once a week, either private or
- •professional). Study partner does not need to attend visits with the
- •patient but must be reachable by phone. Study partner should preferably
- •be the same person throughout the study, if possible
- •Professional study partner (e.g. study nurse, social worker etc.) are
- •allowed if not involved in administering any of the protocol assessments.
- •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 1401
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •or any condition that would prevent the patient from participating in the
- •extension trial (e.g. stroke, head trauma, developed dementia, severe
- •uncontrolled movement disorders or other significant condition since
- •enrolment into the parent phase III trial).
- •2. Any suicidal behavior and/ or suicidal ideation of type 5 based on the
- •C-SSRS in parent trial and up to and including Visit 1 of this study.
- •o Patients with Suicidal Ideation type 4 in the C-SSRS (active suicidal
- •thought with intent but without specific plan), in the past 3 months prior
- •to and including Visit 1, can be entered in the study, if assessed and
- •documented by a licensed mental health professional that there is no
- •immediate risk of suicide.
- •3. Patients diagnosed with moderate or severe substance use disorder
- •(other than caffeine and nicotine), as defined in DSM-5 while the patient
- •was in parent trial and prior to Visit 1 of this study.
- •4. Positive urine drug screen = 3 times during the treatment period of
- •trial 1346-0011, 1346-0012 or 1346-0013 based on central lab test.
- •5. Patients who are currently or wish to participate in another
- •investigational drug trial.
- •6. Any clinically significant finding in the judgment of the investigator
- •o Clinically significant finding on he Physical examination and/or ECG
- •from the last assessment done in the parent trial.
- •o Vital signs (including blood pressure (BP) and pulse rate (PR)) that
- •would jeopardize the patient´s safety while participating in the trial or
- •their capability to participate in the trial.
- •o Symptomatic/unstable/uncontrolled or clinically relevant concomitant
- •disease or any other clinical condition that would jeopardize the
- •patient´s safety while participating in the trial or capability to
- •participate in the trial.
- •o Significant or unstable physical condition that may require change in
- •medication or hospitalization that would impact cognitive function.
- •7. Any significant central lab findings based on the last available lab
- •result received during the parent trial such as:
- •o Severe renal impairment defined as an eGFR < 30mL/min/1.73m²,
- •o Indication of liver disease, defined by serum levels of either ALT
- •(SGPT), AST (SGOT), or alkaline phosphatase above 3 times upper limit
- •or normal or
- •o Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from
- •baseline and is below lower limit of normal in parent trial (alert 3 from
- •last measure Hb in parental trial)
- •o Patients who meet any of the withdrawal criteria before planned end of
- •treatment (26 weeks) in parent trial.
- •8. Patients who have been diagnosed with hemoglobinopathies during
- •the parent trial.
- •9. Patients with known ongoing severe or serious infection with SARSCoV-
- •10. Known history of HIV and/or known on-going Hepatitis B or C
- •infections. As well as any documented active or suspected malignancy or
- •history of malignancy within 5 years prior to screening, except
- •appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- •11. Women who are pregnant, nursing, or who plan to become pregnant
- •while in the trial.
- 另有 6 项未显示
研究者
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