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Universitätsklinikum Würzburg 

ZIM (Zentrum Innere Medizin)
Haus A3/A4 

Oberdürrbacherstr. 6

97080 Würzburg

ZOM / ZIM

Studien - Virushepatitis

TMC435: A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of atreatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve genotype 1 hepatitis C-infected subjects (TMC435-TiDP16-C205)

TMC435: A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNα-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNα-2a/b and RBV therapy (TMC435-TiDP16-C206)

TMC435: A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in hepatitis C, genotype 1 infected subjects who relapsed after previous interferon-based therapy (TMC435HPC3007)

TMC435: A prospective 1-year observational virological follow-up study in subjects previously treated in a Phase IIb or Phase III trial with a TMC435-containing regimen for the treatment of genotype 1 hepatitis C virus (HCV) infection (TMC435HPC3002)

TMC435: A Phase III, open-label, single arm, roll-over trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for subjects who participated in the control (placebo) group of a TMC435 study, or who received short-term (up to 14 days) direct acting antiviral monotherapy in a Tibotec-sponsored study (TMC435-TiDP16-C213)

TMC435: A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNα-2a and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior PegIFNα and ribavirin therapy (PROTOCOL NUMBER: TMC435HPC3001 EUDRACT NUMBER: 2011-001180-53)

TELAPREVIR: Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis (VX-950HEP3002)

OPTEX: OPtimization of treatment for patients with chronic hepatitis C infected with HCV-genotype 2 or 3: 12 vs. 24 weeks of Treatment EXtension for patients without rapid virological response (OPTEX 2/3, Protocol Number: P05498)

REALM: Randomized, observational study of entecavir to assess long-term outcomes associated with nucleoside/nucleotide monotherapy for patients with chronic HBV-infection

DANOPREVIR: A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection (PROTOCOL NUMBER NV22776)

GS-9256, GS-9190: A Phase 2, Randomized, Open-Label Trial of GS-9256 plus GS-9190 alone and in Combination with Ribavirin for 28 Days in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0112)

GS-5885/GS-9451/tegobuvir: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection (Protocol GS-US-248-0131, EudraCT Number: 2011-002748-28)

BMS-650032: A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection (Clinical Protocol AI447016)

BMS-650032, BMS-790052: An Open-Label Re-treatment Study with Peg-Interferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C (EUDRACT Number 2011-000836-27, Clinical Protocol AI444026)

Telbivudin vs. Tenofovir: A randomized, open-label, 104-week treatment study to evaluate the efficacy and safety of lead-in monotherapy of telbivudine or tenofovir with add-on tenofovir or telbivudine at Week 24 in HBeAg-negative patients with chronic hepatitis B (CLDT600A2409)

INFIRE: Induktion der Fibroseregression bei chronischer Hepatitis B Infektion EudraCT-Nr.: 2010-019884-12

ABT-450, ABT-267, ABT-333: A Randomized, open label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 with Ritonavir (ABT-450/r) in combination with ABT-267 and/or ABT-333 with and without Ribavirin (RBV) up to 24 weeks in Treatment-Naïve and Null Responder Subjects with Genotype 1 Chronic Hepatitis C Virus Infection. (M11-652 Protocol EudraCT 2010-022455-31)

BI 201335: Safety and Efficacy of 240 mg BI 201335 once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HC V-co-infected patients. A multinational, randomised, parallel group, open-label trial (EudraCT No.: 2010-021734-59, BI Trial No.: 1220.19)