Klinische Studien


KEK

#No.

Insel

#No.

laufende Studien

 

 

Kohorten

246/00

2985

SCCS - Schweizerische Hepatitis C Kohortenstudie mit Hepatitis C Virus Infizierten: Lack of Physical Activity as a Risk Factor for HCC in Patients with chronic Hepatitis C, Analyse von Blutproben gesammelt im Rahmen der SCCSj-Kohortenstudie.

65/10 1898 Kohortenstudie von Patienten mit HCC, ohne Sponsor, keine Medi, kein Blut, nur Fragebögen (2018-00347).

-

-

NABEL Zirrhosen-Datenbak (Kanada und Bern).

143/15

-

Congenital extrahepatic portosystemic shunts (Abernethy malformation): European Survey of current management strategies and clinical outcome.

362/16

3031

Swiss Hepatitis C Cohort Study: Does pregnancy protect against fibrosis or promote SVR in HCV infected women?

923/16 - Pro-Euro DILI Registry - Creation of a Multicentre and Multidisciplinary European Registry of Prospective Drug-Induced Liver Injury Cases (Pro-Euro-DILI).
922/16   SASL 37: Hepatitis B Kohorte.
2236/16 3320 SASL 40: Swiss cohort on Primary Sclerosing Cholangitis SWISS PSC.
1508/18 - SASL 43: Swiss IgG4 disease cohort.

 

 

Leberkrebs

56/13

2422

BAYER HCC 15982: Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische Studie der Phase III zu Regorafenib bei Patienten mit hepatozellulärem Karzinom (HCC) nach Sorafenib.
Link: BAYER HCC 15982

120/13

2412

ARQ 197-A-U303 (METIV-HCC): A phase 3, randomized, double-blind study of Tivantinib (ARQ197) in subjects with MET diagnostic-high inoperable HCC treated with one prior systemic therapy.
Link: METIV - HCC

192/14

2584

BAY 16728: A prospective, single-arm, multicenter, uncontrolled, open-label phase II trial of Refametinib (BAY 86-9766) in combination with Sorafenib as first line treatment in patients with RAS mutant Hepatocellular Carcinoma (HCC.
Link: BAY HCC 16728

071/15

2756

OPTIMIS - „Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib“ (Ergebnisse von HCC-Patienten bei Behandlung mit TACE, entweder gefolgt von Sorafenib oder nicht gefolgt von Sorafenib, und den Einfluss des Zeitpunkts des Behandlungsbeginns mit Sorafenib).

111/15

2961

LILLY (REACH 2) : I4T-MC-JVDE: Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib” (Lilly).

370/15

3034

Bristol-Myers Squibb Clinical Trial Agreement CA209-459: A randomized, multi-center Phase Ill Study of Nivolumab versus Sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (CheckMate 459).

213/16

-

Tissue Factor in HCC.

075/17 3309 HEPCASUS: Genome studies of hepatocellular carcinoma developed in hepatitis C patients with sustained virolgoical response.
570/17 3494 Novartis PDR001G2101 HCC: A phase Ib study of PDR001 in combination with Sorafenib in patients with untreated advanced hepatocellular carcinoma (HCC).
275/17 3534 Blueprint HCC: BLU-554-1101 A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BLU-554 in Patients with HCC.

 

 

Virale Hepatitis

125/12

2224

HBV-Genomics: Human Genomics of Fulminant Hepatitis B Infection.

208/13

2488

GS-US-337-0124: A phase 2, multicenter, open-label study to investigate the safety and efficacy of sofosbuvir/ledipasvir fixed-dose combination ribavirin administered in subjects infected with chronic HCV who have advanced liver disease or are post-liver transplant.

090/14

2569

Investigation of the Endocannabinoid System in Hepatitis C Infection.

140/14

2560

Immunpathogenese Hepatitis B.

141/14

2566

A metabolomic and lipidomic investigation in patients with viral hepatitis.

338/14

2755

Abbvie M14-423: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection ((TOPAZ II)).

265/15

2934

Abbvie M13-590: Endurance I, GNT3 Sof/Riba vs ABT493/ABT530 12 weeks, Genotype 1.

321/15

2955

Abbvie M13-594, Endurance 3: A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection.

655/16  

3078

GS-US-342-2104. A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects with Chronic HCV Infection who have received a Liver Transplant.

1840/16

3258

Abbvie M15-942 Magellan. An open-label, multicenter study to evaluate the efficacy and safety of AT-493/ABT-530 in combination with Sofosbuvir and Ribavirin in chronic hepatitis C (HCV) infected subjects who have experienced virologic failure in AbbVie HCV clinical studies.

2023/16 3249 Bern-Lugano HCV Study: Retrospective analysis of the outcomes of HCV infected individuals in the hospital setting in Switzerland.
1738/16 3319 Hematite: Quality of Life Measurement Using Wrist Actigraphy in HCV Genotype 1 Infected, Treatment Naive Patients Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir Tablets and Dasabuvir Tablets (Viekirax/Exviera; 3D regimen)
110/17 3307 GS-US-337-4063 Safety and Efficacy of Ledipasvir/Sofosbuvir in patients with chronic HCV infection who are on dialysis for end stage renal disease.
1582/17 3527 SMART-C: A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis.
2063/17 - Gilead AIDAA: Effect of HCV clearance by DAA on evolution of AIDS, or: DAA on evolution of AIDs.
2178/17 3604 AbbVie Mythen - Hep C and microbiota: Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir plus Pibrentasvir in Patients with Chronic Hepatitis C Genotypes 1 to 6 (post-marketing).
1968/17 3597 Novartis CVAY736B2201 - A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER).

 

 

Metabolische Leberkrankheiten

030/11

2034

NASH EU FLIP Cohort EU-FLIP Cohort of patients with non-alcoholic steatohepatitis.
Homepage: FLIP

063/12

2554

Nashville2, Enquête transversale multicentrique, qui a pour objectif de valider la relation de la signature métagenomique avec ll stade évolutif de la stéatohépatite.

235/12

2307

SASL 34 Treatment of non-alcoholic steatohepatitis (NASH) patients with vitamin D. A randomized, double blind, placebo-controlled multicentre phase II trial in patients with fatty liver disease.
Link: NASH Vitamin D3

324/15

3042

Intercept 747-303 NASH (REGENERATE): A phase 3, double-blind, randomized, long-term, placebo-controlled, multicenter study evaluating the safety and efficacy of obeticholic acid in subjects with nonalcoholic steatohepatitis NASH.

1003/16

 3225

GENFIT: Resolve-it: Genfit GFT505 in NASH phase 3: A multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of elafibranor in patients with non-alcoholic steatohepatitis NASH and Fibrosis (Emricasan).

1418/16

3263

Conatus IDN-6556-14 A Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension.  (ENCORE-PH).

2129/16

3287

NATIVE: A randomized, double-blind, placebo-controlled, multicenter, dose-range, proof-of-concept, 24-week treatment study of IVA337 in adult subjects with nonalcoholic steatohepatitis (NASH).

1959/16

3293

GS-US-402-1852 NASH: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH).

1542/16

3207

GS-US-416-2124 (A Phase 2, double blind, randomized study evaluating the safety, tolerability and efficacy of GS-4997 in combination with prednisolon versus prednisolon alone in subjects with severe alcoholic hepatitis (AH).

971/17 3449 NOVARTIS NASH CCLMB763X2201: A randomized, patient and investigator blinded, placebo-controlled, multicenter study to assess the safety, tolerability, pharmacokinetics and efficacy of LMB763 in patients with NASH.
294/18 - Litmus - The European NAFLD Registry Liver Investigation: Testing Marker Utility in Steatohepatitis.

 

 

Zirrhose

073/12

-

PMSR, Sequana Medical AG ALFApump-System Post-Market-Beobachtungsregister - Zur Unterstützung der folgenden Indikation: Automatische Entfernung überschüssiger Peritonealflüssigkeit in die Harnblase bei Patienten mit Zirrhose sowie mit persistenter und refraktärer Aszites, Code: 2011-AAR-004.

038/14

2708

INFECIR-2: Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontenous bacterial peritonitis and high risk of hospital mortality SCNTP880.

076/14

-

Genotypic and Phenotypic Characterisation of Albumin in Cirrhotic Patients.

198/15

2854

Prosper: Phase IV observational hepatic encephalopathy +/- rifaximin.

075 /17

3284

SASL 36: The health burden of Primary Biliary Cirrhosis in Switzerland.

741/16

3090

Patients with Liver Cirrhosis: Analysis of the clinical and Radiological Characteristics of Large Spontaneous Portosystemic Shunts and Analysis of Muscle Mass depletion as a Predictor in Morbidity.

501/17 3303 The added value of CAP in advanced chronic liver disease.
291/17 3337

Predicting Acute-on-Chronic Liver Failure in Cirrhosis.

306/17 - Agua: Alfapump system versus transjugular intrahepatic portosystemic shunt and paracentesis in the treatment of ascites. A multicentre randomised controlled study (Agua-Trial).
524/17 3339

Exalenz. Clinical Study of the BreathID® MCS System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis. Protocol No. CSPH-EX-0414.

548/17 3352 GS-US-384-1944 Cirrhosis on NASH: A Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Selonsertib in subjects with compensated cirrhosis due to NASH (Stellar-4).
550/17 3353 GS-US-384-1943 NASH and bridging cirrhosis (Stellar-3).
168/17 3535 OLT for refractory ascites.

 

 

Vaskuläre Lebererkrankung

 213/13

 2492

SASL 35: Swiss Liver Venous Thrombosis Study: A multicenter prospective observational cohort study.

 

 

Autoimmune Lebererkrankungen

1665/16

3272

SASL 38: Swiss Registry on Autoimmune Hepatitis.

1666/16

3253

SASL 39: Swiss Registry on Primary Biliary Cholangitis.

2236/16 3320 SASL 40: Swiss cohort on Primary Sclerosing Cholangitis SWISS PSC.
1968/17 3597 Novartis CVAY736B2201 - A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER).
1508/18 - SASL 43: Swiss IgG4 disease cohort.

 

 

Andere

143/15 - Congenital extrahepatic portosystemic shunts (Abernethy malformation): European Survey of current management strategies and clinical outcome.

366/15

3004

Intercept 747-302 COBALT: A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter
Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis (protocol number 747-302).

 001/16

 2959

SARCOPENIA: Quality Assessment in hepatic hemodynamic procedures at Inselspital: Radiation exposure, iodine contrast use and procedure related complications.

1353/16 - Quantitative analysis of speed of sound ultrasound images in patients with chronic liver disease.
932/16 3135 T-cell response in DILI (Amendment to DILI).

0148/17

3274

Hemophagocytosis.

957/17 3411 Association between imaging biomarkers of body composition and prognosis in patients with advanced chronic liver disease and in patients with hepatocellular carcinoma (HCC) (Retrospective study with further use of health-related personal data).
487/18 - Combination of non-invasive Tests in chronic liver disease to improve a stage-targeted risk stratification and outcome prediction.

 

 

Abgeschlossene Studien

 

 

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