Criteria for Study Termination. Sage Therapeutics may terminate this study or any portion of the study at any time for safety reasons, including the occurrence of adverse events or other findings suggesting unacceptable risk to subjects, or for administrative reasons. In the event of study termination, Sage Therapeutics will provide written notification to the Investigator. Investigational sites must promptly notify their Institutional Review Board (IRB) and initiate withdrawal procedures for participating subjects.
Criteria for Study Termination. Conditions may arise during the study that could prompt the study to be halted. Conditions that may prompt such considerations include, but are not limited to, the following: • The discovery of unexpected, serious, or unacceptable risk to subjects enrolled in the study; • A decision on the part of the sponsor or regulatory authority to suspend, discontinue, or shorten the study • Study conduct at a study site may warrant termination under conditions that include the following: − Failure of the site to enroll eligible subjects into the study; − Failure of the investigator to comply with FDA, country-specific, or local regulations; − Submission of false information from the research facility to the sponsor, the clinical Monitor, or a regulatory authority; − Insufficient adherence to protocol requirements; − A conflict of interest on the part of the investigator, his/her institution, or site personnel that would negatively impact the integrity of the clinical trial; − Institution, site, investigator, or IRB/ICE under investigation for cause by a regulatory agency.
Criteria for Study Termination. Although the Sponsor intends to complete the study, the Sponsor reserves the right to discontinue the study at any time for clinical or administrative reasons, or if required by regulatory agencies. If the Sponsor discontinues the study, all study drug will be discontinued and the investigator will be responsible for securing any alternative therapy to be administered, as appropriate.
Criteria for Study Termination. This study may be prematurely terminated by La Jolla for any reason. Written notification documenting the reason for study termination will be provided to the Investigator by Xx Xxxxx. Circumstances that may warrant termination include, but are not limited to: • Determination of unexpected, significant, or unacceptable risk to patients • Unacceptable patient enrollment rate • Insufficient adherence to protocol requirements • Insufficient complete and/or evaluable data • Plans to modify, suspend, or discontinue development of LJPC-501 Table 4: Schedule of Assessments Assessment Screening1 (-48 to -2 hr) Baseline Day 1 0 to 2 hours Day 1 2 to < 24 hours Hour 24 (± 1 hr) Days 2 to 6 EOS2 Day 7 to 10 (± 6 hr) Day 28 Follow-up (± 2 days) Informed Consent3 X Titrate SOC Vasopressors4 X X X (X) (X)5 Inclusion/Exclusion Criteria X Demographics X Medical/Surgical History X Limited Physical Exam6 X X Chest X-ray7 X Hemodynamic Xxxxx Xxxxx (HR, MAP)8 X X X X X X X Other Xxxxx Xxxxx (BP, RR, Body Temperature)9 X X X X X X 12-Lead ECG10 X X Urine Output11 X X X X X X X5 Fluid Intake12 X X X X X X X5 Tissue Oxygen Saturation13 X X X Arterial Blood Gas14 X X Serum Lactate15 X X X Serum Pregnancy Test16 X Hematology and Serum Chemistry17 X X Angiotensin I/II levels 18 X LJPC-501 Administration19 X X X (X) (X)5 Assessment Screening1 (-48 to -2 hr) Baseline Day 1 0 to 2 hours Day 1 2 to < 24 hours Hour 24 (± 1 hr) Days 2 to 6 EOS2 Day 7 to 10 (± 6 hr) Day 28 Follow-up (± 2 days) PELOD/PRISM/PIM2 Scoring, Including20 Pupillary Reactions Glasgow Coma Score Diagnosis Ratings X X Concomitant Medications and Concomitant Procedures21 X X X X X X X X Safety Assessments (AEs/SAEs)22 X X X X X X Abbreviations: ABG=arterial blood gas; AE=adverse event; BP=blood pressure; ECG=electrocardiogram; EOS=End of Study; HR=heart rate; MAP=mean arterial pressure; PELOD=Pediatric Logistic Organ Dysfunction; PIM2=Pediatric Index of Mortality 2; PRISM=Pediatric Risk of Mortality; RR=respiratory rate; SAE=serious adverse event; SOC=standard of care. 1 Screening procedures may be conducted up to 48 hours prior to anticipated initiation of LJPC-501 dosing. SOC procedures collected prior to informed consent may be used to qualify patients for the study.
Criteria for Study Termination. Unacceptable safety signals will prevent moving to the next higher dose cohort or result in stopping the study, including any of the following, if deemed to be related to study drug RBM-007 (distinct from complications related to the i.vt. injection procedures): • A pattern of systemic AEs • Any of the following AEs in any 2 subjects in any cohort: • Retinal non-perfusion/vascular occlusion of the study eye • Retinal vasculitis • Retinitis • > 2+ disc edema • > 2 quadrants of retinal hemorrhage
