Protocol Title. Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials Protocol Date: 28 January 2019 Sponsor: Merck KGaA Country where Provider is Conducting Study Czech Republic Location where the study will be conducted: Faculty of hospital Motol, Číslo Protokolu: MS700568_0026 Název Protokolu: Posouzení dlouhodobých výsledků a trvalosti účinku po léčbě roztroušené sklerózy tabletami kladribinu: Explorativní, ambispektivní klinické hodnocení fáze IV u pacientů, kteří se dříve účastnili klinických hodnocení CLARITY/CLARITY-EXT a ORACLE MS Datum Protokolu: 28 Leden 2019 Zadavatel: Merck KGaA Stát ve kterém má sídlo Poskytovatel, který provádí Studii Česká republika Místo, kde bude prováděna Studie: Fakultni nemonice v Motole, Neurologická klinika 2. LF UK a FN Motol Key Enrollment Date: And study period 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) Patients to be enrolled ECMT / EC / RA Ethics committee (EC) Faculty of hospital(FN) Ostrava 17. listopadu 1790/5 708 52 Ostrava-Poruba; /Ethics Committe Faculty of hospital Motol V úvalu 84 150 06 Praha 5 – Motol, / State Institute for Drug Control [Investigator name], (the “Investigator”) ,MD, PhD. Klíčové datum zařazení & předpokládáná doba studie: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 “Klíčové datum zařazení”) MEK / EK / SÚKL Etická komise (EK) Fakultní nemocnice (FN) Ostrava 17. listopadu 1790/5 708 52 Ostrava-Poruba;. Etická komise Fakultní nemocnice v Motole V úvalu 84 150 06 Praha 5 – Motol, / Statni ustav pro kontrolu leciv; [Jméno zkoušejícího], ( “Zkoušející”) , Ph.D. The following additional definitions shall apply to this Agreement: Case Report Form or CRF: case report form (paper or electronic) to be used by Site to record all of the Protocol-required information to be reported to Sponsor on each Study Subject (defined below).
Protocol Title. (Insert Details) Sponsor: (Insert Details) Entered into by and between: (Hereinafter, “the Provider”) Registered Physical address of Provider: Wits Health Consortium (Pty) Ltd, a wholly owned company of the University of the Witwatersrand, Johannesburg 31 Princess of Wales Terrace, Parktown Johannesburg, 2193 Registered physical and postal address of Principal Investigator: Email: xxx@xxxxxxxxxx.xx.xx Tel: Fax: Cell: Email: (Hereinafter, “the Recipient”) Registered physical and postal address of Recipient: Tel: Fax: Cell: Email: (Hereinafter, “the Human Research Ethics Committee”) Registered physical and postal address of Human Research Ethics Committee: University of the Witwatersrand Human Research Ethics Committee (Medical) Research Office, Senate House University of the Witwatersrand, 0 Xxx Xxxxx Avenue, Braamfontein, Johannesburg, 2000 Tel: 000 000 0000 Fax: 000 000 0000 Email: xxx@xxxxxxxxxx.xx.xx
Protocol Title. A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY) Protocol Date: February 14, 2020 2.1 Risk / Benefit Assessment 8 3.1 Study Overview 9 4.1 Primary Objective 11 4.2 Secondary Objectives 11 4.3 Exploratory Objectives 12 5.1 Primary Endpoint 12 5.2 Secondary Endpoints 12 6.1 Study Population 13 6.2 Eligibility Criteria at Screening 13 6.3 ELIGIBILITY CRITERIA AT RANDOMIZATION (VISIT 1, DAY 0) 15 6.4 ADDITIONAL ELIGIBILITY FOR MUCUS BIOLOGY AND CLEARANCE (MCC) 15 6.5 Study Specific Tolerance for Eligibility Criteria 16 6.6 Screen Fail Criteria 16
Protocol Title. A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Název Efficacy and Safety of the Protokolu: Proposed Aflibercept FYB203 Biosimilar in Randomizované, dvojitě maskované, multicentrické klinické hodnocení fáze 3 porovnávající účinnost a bezpečnost přípravku FYB203 (navrhované Comparison to Eylea® in Patients with Neovascular Age-Related Macular Degeneration (MAGELLAN- AMD) biologické obdoby afliberceptu) v porovnání s přípravkem Eylea® u pacientů s věkem podmíněnou neovaskulární makulární degenerací (MAGELLAN-AMD)
Protocol Title. A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination with Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old with Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia Název protokolu: Dvojitě zaslepená, placebem kontrolovaná studie fáze 3 přípravku Quizartinib (AC220) podávaného v kombinaci s indukční a konsolidační chemoterapií a jako udržovací léčba u pacientů ve věku 18 až 75 let s nově diagnostikovanou akutní myeloidní leukémií FLT3-ITD (+)
Protocol Title. “A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS)” Protocol Date: 20 August 2020 Sponsor: Merck Healthcare KGaA Country where Site is Conducting Study Czech Republic Location where the study will be conducted: Neurology clinic, which is a division/part of the Institution Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.9 “Key Enrollment Date” below)
Protocol Title. A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Název Protokolu: Multicentrické, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2b s paralelními skupinami, posuzující účinnost a bezpečnost perorálního etrasimodu jako indukční léčby u pacientů se středně až vysoce aktivní Crohnovou nemocí
Protocol Title. A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy
Protocol Title. A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity
Protocol Title. A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy. Pursuant to 21 CFR 312.52 and ICH E6, the following obligation(s) of the Sponsor, Oramed Ltd. have been transferred to: CRO Name: Integrium, LLC CRO Address: 00000 Xxxxxx Xxxx Xxxxxx, XX 00000 Obligation Assigned to:1
