Northeim, Germany
EndoRings Colonoscopy for Adenoma Detection
Phase
N/ASpan
92 weeksSponsor
Helios Albert-Schweitzer-Klinik NortheimNortheim
Recruiting
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
Primary objectives This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives: Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology. Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives Key secondary objectives of Part 1: - To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis - To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH Other secondary objectives of both Part 1 and Part 2: - To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period) - To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period) - To assess the effect of lanifibranor on liver tests - To assess the effect of lanifibranor on glycaemic parameters - To assess the effect of lanifibranor on lipid parameters - To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography. - To assess the effect of lanifibranor on health-related quality of life - To assess the safety of lanifibranor - To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)
Phase
3Span
267 weeksSponsor
Inventiva PharmaNortheim
Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.
Phase
N/ASpan
242 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyNortheim
Recruiting
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
Phase
N/ASpan
309 weeksSponsor
Helios Albert-Schweitzer-Klinik NortheimNortheim, Lower Saxony
Recruiting
Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Phase
N/ASpan
305 weeksSponsor
Helios Albert-Schweitzer-Klinik NortheimNortheim, Lower Saxony
Recruiting