Protocole ID COG-AEWS1221 ClinicalTrials.gov ID NCT02306161 Type(s) de cancer Pédiatrique divers Phase Phase III Institution CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE Ville Montréal Investigateur principal Dr Yvan Samson Coordonnateur Martine Therrien 514-345-4931 poste 3396 Statut Fermé <> Title: … <>>> We found that 2-year progression-free survival in patients with bladder cancer who had robotic cystectomy was non-inferior to that of patients who had open cystectomy. Essai Clinique.  (Clinical Trial), A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older, 18 Years and older   (Adult, Older Adult), Vestavia Hills, Alabama, United States, 35216, Little Rock, Arkansas, United States, 72211, Cerritos, California, United States, 90703, Chula Vista, California, United States, 91911, Montclair, California, United States, 91763, Sacramento, California, United States, 95684, San Diego, California, United States, 92103, Wheat Ridge, Colorado, United States, 80033, Coral Gables, Florida, United States, 33134, Lake Worth, Florida, United States, 33461, North Miami, Florida, United States, 33161, Port Orange, Florida, United States, 32127, Saint Petersburg, Florida, United States, 33709, West Palm Beach, Florida, United States, 33409, The South Bend Clinic Center for Research, South Bend, Indiana, United States, 46617-2808, Lake Charles, Louisiana, United States, 70601, Rockville, Maryland, United States, 20850, Neptune, New Jersey, United States, 07753, Albuquerque, New Mexico, United States, 87102, Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center, Rochester, New York, United States, 14618, Staten Island, New York, United States, 10312, Charlotte, North Carolina, United States, 28207, Wilmington, North Carolina, United States, 28401, Oklahoma City, Oklahoma, United States, 73112, Charleston, South Carolina, United States, 29425, Nashville, Tennessee, United States, 37203, Salt Lake City, Utah, United States, 84107. Routine study visits will not be considered medically-attended visits. > essai clinique. uf���f���"¯ԛ�0�} The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older: Actual Study Start Date : September 7, 2020: ... -19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of this protocol: fever or chills, … U.S. Department of Health and Human Services. The results of this study may have important implications for implementing the knowledge on the etiology of DS and may be useful to develop new therapeutic approaches. MAAEs are defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. New onset of chronic diseases will be collected as part of the MAAEs. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Clinical trial protocol Title An Exploratory, Open Label, Non-randomized, Within-patient Multiple Dose- ... Trial phase Phase II Drug EVEROLIMUS International multicenter study ClinicalTrials.gov Identifier: NCT01059318 . The viral load of SARS-CoV-2 will be assessed in confirmed COVID-19 cases using RT-PCR. Un homme est en état de mort cérébrale et cinq autres personnes sont hospitalisées ce vendredi à Rennes, suite à l'essai clinique d'un médicament. Protocole ID CA209-9DX. b�N�U�@��*_�A�?} Participants receive the treatment determined by randomization for a maximum of 4 years or until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or death (whichever occurs first). This is the first phase 3 trial comparing robot-assisted cystectomy with open cystectomy for any urological cancer. With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection. Ad26.COV2.S, a COVID-19 vaccine based on a human replication-incompetent Ad26 vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, is being developed. In this phase 3 trial, subcutaneous administration of the anti-interleukin-17A monoclonal antibody secukinumab significantly improved the signs and symptoms of psoriatic arthritis versus placebo. Currently, there are no approved vaccines for the prevention of COVID-19. For Part 2 (Dose Expansion): The participant must have histological or cytological … Groups 1, 7 & 9 are adults aged 56-69 years; groups 2, 8 & 10 are adults 70 years and over; groups 4, 5 & 6 are adults aged 18-55 years; group 11 is adults aged 18-55 years who have previously received a ChAdOx vectored vaccine; group 12 is HIV positive adults … 3. \=h�� j�L�CFr�5>?1�Q-���ҐZ�P�w �iſ���vj Phase 2 Phase 3: Detailed Description: There will be 11 study groups and it is anticipated that a total of 12,390 volunteers will be enrolled. endobj For general information, Learn About Clinical Studies. Participants will also be instructed on how to note signs and symptoms in the e-Diary on a daily basis for 7 days post each vaccination (day of each vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia. Ces essais visent principalement à étudier la tolérance au médicament et à définir la dose et la fréquence d'administration qui seront recommandée… Participants will be instructed on how to record daily temperature using a thermometer provided for home use. x��Z�o�6��A�R��E������f�-��^z���l+�[G��r����|���X��C�X��pf8���w�f�T���o�Xm˵����>�6�z(�?�]U4��Z,������������D�=>��/�?�Q���K�8����|{y�����/���=����;���8OC����c?��X��'�(LxB�`���s�)S����'�h��țE!�rJ�e���ۛ�~�UF��I��E��=���ono`]��{�m��MS?�+4�2b�J� His history in vaccine development includes serving in Bihar, India for … MPOWERED: A phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of … Choosing to participate in a study is an important personal decision. %�o��]��>�Ѐ'j#jKG��c?��� <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.32 841.92] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Généré le 06 janv. Essai clinique de phase I par oligonucléotides immunostimulants (CpG-ODN) dans les glioblastomes en récidive (protocole ISOPS I) November 2005 Neurochirurgie 51(5):550-550 By: ... including the study protocol. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Biophytis – Approbation par la FDA et l’AFMPS de l’amendement apporté au protocole de SARA-INT, essai clinique de phase 2b sur Sarconeos (BIO101) dans la sarcopénie ... Approbation par la FDA et l'AFMPS de l'amendement apporté au protocole de SARA-INT, essai clinique de phase 2b sur Sarconeos (BIO101) dans la sarcopénie 11 Feb 2020 08:00 CET Company Name BIOPHYTIS. Un essai clinique de phase I avec augmentation progressive des doses commence aux États-Unis dans des centres académiques très expérimentés sous le parrainage d'OBT. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. ... pharmacokinetics and pharmacodynamics of an investigational medicinal product. The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. À propos de Menarini Nasal swabs will be used to detect and/or quantify SARS-CoV-2. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. protocole d’essai clinique de phase iii Version n°3.0 du 27 Septembre 2007 Approuvée par le Ministre de la Santé et de l‘Hygiène Publique de Côte d‘Ivoire, après avis 'x� �V����T�5*����Ge\+׫�KK�*̒I��$z�a���c�6�����+ϡXw�jF�͎*�pH�a��� /-�!��I��g$ԳND���4�9��Ɔ�x � Essai Clinique Généré le 24 nov. 2020 à partir de Titre A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation Protocole ID AG-221-AML-004 �d��%�( S���`&���c_��y1q����h��99��ʑ��E ��X�>�I�[6h=�����_Tkl����^h\������� endobj Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary. and. This is a phase 3 multicenter, open-label, randomized study in participants with relapsed or refractory multiple myeloma (RRMM) who have received 1 to 3 prior therapies. doi : 10.1136/bmjopen-2019-034362 … Les essais de phase I/II sont une variante des essais de phase I, ils permettent une évaluation préliminaire de l'efficacité à la dose sélectionnée ou bien de tester des combinaisons de médicaments. ... Study protocol for a pilot single-site phase I/II randomised placebo controlled trial Daryl Efron, Kaitlyn Taylor, Jonathan M Payne, Jeremy L Freeman, Noel Cranswick, Melissa Mulraney, Chidambaram Prakash, Katherine J Lee, Katrina Williams BMJ Open, 2020, 10, e034362. Masking: None (Open Label) ... Biopsy is allowed by protocol if no histology or cytology records are available. Talk with your doctor and family members or friends about deciding to join a study. Les essais de phase Icorrespondent le plus souvent à la première administration d'un médicament à l'homme. ... Dr. Said Ghandour, Dept.de Biopathologie et Imagerie de la Myéline, CNRS/ULP, Strasbourg, France. This is followed by Part 2, which involves parallel dosing of 3 different cohorts at the dose determined in Part 1. Ad26.COV2.S vaccine will be administered on Day 1 and Day 57. IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S. ... Pnuez Created Date: 04/16/2020 05:40:00 Title: ANX5 2009 - Courrier de demande d’autorisation d’essai clinique (AEC) Last … SARS-CoV-2 binding antibodies as assessed ELISA to measure humoral immune response will be reported. 1 0 obj Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) with onset at least 14 days after second vaccination (Day 71) to end of Study (2.3 years) will be reported. Information provided by (Responsible Party): The study will enroll up to 30,000 participants in order to evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in adult participants. Serologic conversion between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination using an ELISA and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 nucleocapsid (N) protein will be reported. The total study duration will be maximum 2 years and 3 months for the participants. �i��k� �y�. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu, https://www.janssen.com/clinical-trials/transparency. Essai Clinique. Participants should record the temperature in the e-Diary in the evening of the day of each vaccination, and then daily for the next 7 days approximately at the same time each day. Ils incluent en général un petit nombre de malades (10 à 40). Title: Protocole … or Ablation. This ... Microsoft Word - PI_essai_clinique_bial_220116 bis version finale_EN_2.docx The study protocol is available from the funder. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Please remove one or more studies before adding more. To learn how to participate in this trial please click here. The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate. Participants will receive intramuscular (IM) injection of Ad26.COV2.S vaccine on Day 1 and Day 57. Placebo will be administered as IM injection on Day 1 and Day 57. <> 2 0 obj Assessments like efficacy (COVID-19 like signs and symptoms, etc), immunogenicity (such as humoral immune responses), and safety (such as AEs monitoring) will be performed throughout the study. These are phase 1, or phase 1-2 clinical trials (if the phase 1 takes place on the French territory). Clinical trial with complex design: C. linical trial with multiple . Part 1 employs a dose-escalation design to determine the recommended phase 2 dose. Evidence before this study. In its evaluation ANSM, took into account the European recommendation on first-in-man administration. ISN … COVID-19 is an emerging, rapidly evolving situation. ... PP=per-protocol. mITT=modified intention-to-treat. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Bayern ... multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment (Phase IV) - ES ... ALZIRA. Research in context. This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. �ў��>+��̗�Qg���弮(4o{����������5�����A�6�H��h�^� �&c�i����O�(��K(],�*c5�d�n @����g/�Rf���@�Z�K���M���x�8 o �)�*a��2� �|��i�7�����j�DH�}M�kZ83���� A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of DCC-2618 vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib: Protocole ID : intrigue (DCC-2618-03-002) ClinicalTrials.gov ID : NCT03673501: Type(s) de cancer : Tumeur stromale gastro-intestinale: Phase : Phase III: Stade Participants will receive IM injection of placebo on Day 1 and Day 57. Molecularly confirmed moderate and severe/critical COVID-19 defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case definition at the time of finalization of this protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea. The only change was the investigator's name, approved by the CPP on November 4, 2015. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of their Serostatus [ Time Frame: 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 1 day after the 1st vaccination (Day 2) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 and who were Seronegative at Baseline [ Time Frame: 14 days after the 1st vaccination (Day 15) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of COVID-19 Requiring Medical Intervention [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants with Molecularly Confirmed, Moderate to Severe/Critical COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly Confirmed Mild COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with First Occurrence of Molecularly confirmed COVID-19 Defined by the US FDA Harmonized Case Definition [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Serologic Conversion Between Baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination Using an Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Between baseline (Day 1) and 14 days, 6 months, and 1 year after the 2nd vaccination ], Number of Participants with First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) [ Time Frame: At least 14 days after the 2nd vaccination (Day 71) to end of study (2 years and 3 months) ], Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after second vaccination (Up to 34 weeks) ], Number of Participants with Medically-attended Adverse Events (MAAEs) Leading to Study Discontinuation [ Time Frame: Up to 2 years and 3 months ], Number of Participants with Solicited Local Adverse Events (AEs) During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Solicited Systemic AEs During 7 Days Following Each Vaccination [ Time Frame: Up to Day 8 (7 days after first vaccination on Day 1), up to Day 64 (7 days after second vaccination on Day 57) ], Number of Participants with Unsolicited Local Adverse Events (AEs) During 28 Days Post-vaccination [ Time Frame: Up to Day 29 (28 days after first vaccination on Day 1), up to Day 85 (28 days after second vaccination on Day 57) ], SARS-CoV-2 Binding Antibodies Assessed by ELISA [ Time Frame: Up to 2 years and 3 months ], SARS-CoV-2 Neutralizing Antibody Titers as Assessed by Virus Neutralization Assay (VNA) [ Time Frame: Up to 2 years and 3 months ], Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies, All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration, Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine, Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study, Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs), Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor, Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients, Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine, Participant previously received a coronavirus vaccine, Participant received an investigational drug within 30 days (including investigational drugs for prophylaxis of COVID-19) or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or investigational monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study. %���� A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older: Actual Study Start Date : November 15, 2020: Estimated Primary Completion Date : May 10, 2022: Estimated Study Completion Date : May 11, 2023 endobj BOD will be evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate, or severe/critical COVID-19 case. Essais cliniques. Mild COVID-19 includes: Fever, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, or chills, without shortness of breath or dyspnea. 3 0 obj OSE Pharma : Protocole d’essai clinique de phase 3 pour OSE-­‐2101 accepté par la FDA et l’EMA OSE Pharma reçoit les avis positifs pour préparer l’essai clinique de phase 3 d’enregistrement pour OSE-­‐2101, son vaccin thérapeutique contre le cancer du poumon « non à petites cellules » (NSCLC) Paris, 23 juin 2014 – OSE Pharma SA, …