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A Phase 2B, Randomized, Multicenter, Double Title: A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance NCT Number: NCT03477903 Protocol Approve Date: 28 February 2018 Certain information within this protocol has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable information (PPD) or company confidential information (CCI). This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. • Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. TAKEDA PHARMACEUTICALS PROTOCOL A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance Sponsor: Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited Please note: Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, may be referred to in this protocol as “Millennium,” “Sponsor,” or “Takeda”. Study Number: 2002 IND Number: 114408 EudraCT Number: 2017-003206-41 Compound: TAK-954 Date: 28 February 2018 Version/Amendment 01 Number: Amendment History: Amendment Type (for regional Date Amendment Number Europe purposes only) Region 16 Jan 2018 Initial version Not applicable Global* 28 February 2018 01 Nonsubstantial Global* CONFIDENTIAL PROPERTY OF TAKEDA This document is a confidential communication of Takeda. Acceptance of this document constitutes the agreement by the recipient that no information contained herein will be published or disclosed without written authorization from Takeda except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Furthermore, the information is only meant for review and compliance by the recipient, his or her staff, and applicable institutional review committee and regulatory agencies to enable conduct of the study. TAK-954 Study No. 2002 Page 2 of 95 Protocol Incorporating Amendment No. 01 28 February 2018 1.0 ADMINISTRATIVE INFORMATION 1.1 Contacts A separate contact information list will be provided to each site. Takeda Development Center Americas, Inc. (TDC) sponsored investigators per individual country requirements will be provided with emergency medical contact information cards to be carried by each subject. General advice on protocol procedures should be obtained through the monitor assigned to the study site. Information on service providers is given in Section 3.1 and relevant guidelines provided to the site. Contact Type/Role Country Contact Serious adverse event and pregnancy reporting PPD Medical Monitor (medical advice on protocol and study drug) Responsible Medical Officer (carries overall responsibility for the conduct of the study) CONFIDENTIAL TAK-954 Study No. 2002 Page 3 of 95 Protocol Incorporating Amendment No. 01 28 February 2018 1.2 Approval REPRESENTATIVES OF TAKEDA This study will be conducted with the highest respect for the individual participants in accordance with the requirements of this study protocol and also in accordance with the following: ! The ethical principles that have their origin in the Declaration of Helsinki. ! International Council on Harmonisation E6 Good Clinical Practice: Consolidated Guideline. ! All applicable laws and regulations, including, without limitation, data privacy laws, clinical trial disclosure laws, and regulations. SIGNATURES The signature of the responsible Takeda medical officer can be found on the signature page. Electronic Signatures are provided on the last page of this document. PPD CONFIDENTIAL TAK-954 Study No. 2002 Page 4 of 95 Protocol Incorporating Amendment No. 01 28 February 2018 INVESTIGATOR AGREEMENT I confirm that I have read and that I understand this protocol, the Investigator’s Brochure, package insert and any other product information provided by the sponsor. I agree to conduct this study in accordance with the requirements of this protocol and also to protect the rights, safety, privacy, and well-being of study subjects in accordance with the following: The ethical principles that have their origin in the Declaration of Helsinki. International Council on Harmonisation, E6 Good Clinical Practice: Consolidated Guideline. All applicable laws and regulations, including, without limitation, data privacy laws and regulations. Regulatory requirements for reporting serious adverse events defined in Section 10.2 of this protocol. Terms outlined in the study site agreement. Responsibilities of the Investigator (Appendix B). I further authorize that my personal information may be processed and transferred in accordance with the uses contemplated in Appendix D of this protocol. Signature of Investigator Date Investigator Name (print or type) Investigator’s Title Location of Facility (City, State/Province) Location of Facility (Country) CONFIDENTIAL TAK-954 Study No. 2002 Page 5 of 95 Protocol Incorporating Amendment No. 01 28 February 2018 1.3 Protocol Amendment 01 Summary of Changes Rationale for Amendment 01 This document describes the changes in reference to the protocol incorporating Amendment No. 01. The primary reason for this amendment is the clarification and correction of study procedures. Minor grammatical, editorial, and formatting changes are included for clarification purposes only. For specific descriptions of text changes and where the changes are located, see Appendix F. Changes in Amendment 01 1. CCI 2. CCI 3. Deletion of the reinstitution of subjects’ treatment in case of relapse. 4. Additional criteria for discontinuation or withdrawal of a subject was added. 5. Clarification of neurological examinations. 6. Removal of glycosylated hemoglobin (HbA1c) and thyroid stimulating hormone testing. 7. Correction of electrocardiograms (ECGs) time points. 8. Correction of clinical laboratory sample collections and amount of blood needed for the study. 9. Clarification of cardiovascular adverse events of special interest (AESI). 10. Deletion of the submission of the original copy of the serious adverse event (SAE) form to the sponsor. 11. Clarification of the collection of height measurement. 12. Correction of time from Randomization to drug administration. CONFIDENTIAL TAK-954 Study No. 2002 Page 6 of 95 Protocol Incorporating Amendment No. 01 28 February 2018 TABLE OF CONTENTS 1.0 ADMINISTRATIVE INFORMATION ...........................................................................2 1.1 Contacts.....................................................................................................................2 1.2 Approval....................................................................................................................3 1.3 Protocol Amendment 01 Summary of Changes ..........................................................5 2.0 STUDY SUMMARY ....................................................................................................11 3.0 STUDY REFERENCE INFORMATION ......................................................................16 3.1 Study-Related Responsibilities.................................................................................16 3.2 Principal Investigator/Coordinating Investigator ......................................................16 3.3 List of Abbreviations ...............................................................................................17 3.4 Corporate Identification ...........................................................................................19 4.0 INTRODUCTION.........................................................................................................20 4.1 Background .............................................................................................................20 4.2 Rationale for the Proposed Study.............................................................................22 4.3 Benefit/Risk Profile .................................................................................................24 5.0 STUDY OBJECTIVES AND ENDPOINTS..................................................................25 5.1 Objectives................................................................................................................25 5.1.1 Primary Objective ..............................................................................................25 5.1.2 Secondary Objectives.........................................................................................25 5.1.3 Exploratory Objectives.......................................................................................25 5.2 Endpoints.................................................................................................................25 5.2.1 Primary Endpoint ...............................................................................................25 5.2.2 Secondary Endpoints..........................................................................................26 5.2.3 Safety Endpoints................................................................................................26
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