To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The protocol approved by ANSM on June 2015 was subjected to a modification request in October. 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 . l C�4�X$~����}i�0�gx��v�τbd=��ȡ���m�ln�N�آȡ�>�S��S�L�VSi���� :y����+��@��W[Ry_W�bHKt-�b�q5����Nh�L\��sv��g����_��8�Oo�Yf�u�޺��_�++��O�H���~��DA�u_�H����:"�մ��| ��aj����Y�gdY�����]>�+�'2���]sc����iM5����Z��x�}�����:֘M �AE��!�� wΣ�F/�l�d�Ɔw�~�8����im�J�HcVΡ��e�!��ԗ�Ͷ@���Ee\ 9y�tj����{�����S�sǼ�=�dV�ב�/�0������$�������^��q��g=����Szg�w�S�"س�A��t��_��_�$�0D�z���ʕ��L����+�����b5�٢�� �������B�76 ܓ\�Y 8A��>�� . (sgRi~�=o��m����l ClinicalTrials.gov Identifier: NCT04614948, Interventional ... PP=per-protocol. 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. ... 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. 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. 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. %���� 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. Essai Clinique. This first phase of the registry project will collate clinical and laboratory data from all non-commercial clinical trials for MDS in Europe, retrospectively from 1996, and ... Protocole d’essai clinique Author: 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. With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection. Masking: None (Open Label) ... Biopsy is allowed by protocol if no histology or cytology records are available. Titre A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants. endobj Ad26.COV2.S vaccine will be administered on Day 1 and Day 57. Essais cliniques. ... 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. �. Fever is defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. 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. 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. ... Pnuez Created Date: 04/16/2020 05:40:00 Title: ANX5 2009 - Courrier de demande d’autorisation d’essai clinique (AEC) Last … 2021 à partir de Titre A Randomized, Phase III Trial of Immunization With IMM-101 Versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure Protocole ID COV-IMMUNO (IC8) ClinicalTrials.gov ID NCT04442048 Type(s) de cancer Autre Phase Phase III Type étude Prévention Syndrome myélodysplasique ; Syndrome myélodysplasique Aperçu cartographique; Titre : A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis) … Essai Clinique. 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 … The molecule proved most effective in phase 3, will be tested ‘in vivo’ in order to evaluate its ability to correct the tested molecular aberrations. 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. <>>> The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This ... Microsoft Word - PI_essai_clinique_bial_220116 bis version finale_EN_2.docx 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 and. 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. Essai(s) clinique(s) national(aux) ALLEMAGNE. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) neutralizing antibody titers as assessed by VNA to measure the humoral immune responses will be reported, Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol. �d��%�( S���`&���c_��y1q����h��99��ʑ��E ��X�>�I�[6h=�����_Tkl����^h\������� 4 0 obj COVID-19 is an emerging, rapidly evolving situation. *Patients received the wrong procedure due to screening failure … <>/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. This is the first phase 3 trial comparing robot-assisted cystectomy with open cystectomy for any urological cancer. Improved definition of response predictors by combining data from several studies of the same drugs (including meta-analyses).