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Universitätsklinikum Würzburg 

ZIM (Zentrum Innere Medizin)
Haus A3/A4 

Oberdürrbacherstr. 6

97080 Würzburg

ZOM / ZIM

Hepatitis B

REALM: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection.
Phase IV
Period: 2007-2017
EudraCT-Nr.: 2005-003284-22

OPTIMA: A Randomized, Open-label, 104-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients. (Study Protocol: CLDT600A2409)
Period: 2011-2014
EudraCT-Nr.: 2007-000180-13

INFIRE-001: Induction of Fibrosis Regression regarding Chronic Hepatitis B Infection
Period: 2010-2014
EudraCT-Nr.: 2010-019884-12

PADD-ON: A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated Interferon alfa-2a (Pegasys®) 180 µg once weekly for 48 weeks in addition to an ongoing nucelos(t)id based treatment on quantitative HBsAg levels in patients with chronic HBeAg-negative hepatitis B.
EudraCT-Nr.: 2011-002812-10

Hepatitis C

Boceprevir: A Phase 3, Safety and Efficacy Study of Short Duration Boceprevir/Peg/riba in Chronic HCV Genotype 1 IL28B CC Patients. (Study Protocol No. P07755)
Phase III
Period: 2012-2014
EudraCT-Nr.: 2011-001345-32

TMC435: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects with Chronic Hep. C. (Study Protocol: TMC435HPC3014)
Period: 2013-2014
EudraCT-Nr.: 2012-004905-29

VX-950HEP4002: Telaprevir-basierte Behandlung der Chronischen Hepatitis C GT 1. (NIS)
Period: 2012-2015

PAN: Peginterferon alfa-2a Nichtinterventionelle Studie – Ein Projekt von Roche in Kooperation mit dem bng zur Qualitätssicherung der Kombinations- bzw. Tripletherapie der chronischen Hepatitis C mit Peg-Interferon alfa-2a (Pegaysys®). Period: 2013-2015

ABT-450/ABT-267/ABT-333: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV). (Study Protocol: M11-646)
Period: 2013-2014
EudraCT-Nr.: 2012-002019-25

GSK2336805: A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection
Phase II. (Study Protocol GSH-HAI115879)
Period: 2012-2014
EudraCT-Nr.: 2012-000523-40

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)
Phase IV
Period 2008-2013
EudraCT-Nr.: 2008-000706-36

Alisporivir: A multicenter, open-label, randomized, 3-arm, phase II profiling trial of pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic Hep. C. (Study Protocol: CDEB025A2222)
Period: 2013-2015
EudraCT-Nr.: 2012-004185-17

TMC435: A prospective 3-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. (Study Protocol: TMC435HPC3002)
Phase III
Period: 2011-2012
EudraCT-Nr.: 2010-019843-20

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. (Study Protocol: TMC435-TiDP16-C213)
Phase III
Period: 2011-2015
EudraCT-Nr.: 2011-000416-25

GS-US-248-0122/0123: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection.
Period: 2011-2013
EudraCT-Nr.: 2011-000946-39

Sofosbuvir: An Open-Label Study of GS-7977+ Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection who Participated in Prior Studies Evaluating GS-7977. (Study Protocol: GS-US-334-0109)
Period: 2012-2014
EudraCT-Nr.: 2012-000571-16

PIRB-Studie: HCV Protease-Inhibitor Resistenz-Analyse zur Erfassung von viralen Resistenzen bei Patienten mit chronischer Hepatitis C Genotyp 1 Infektion vor einer Triple-Therapie.
Period: 2014-2015

PISA-Studie: HCV Protease-Inhibitor Resistenz-Analyse zur Erfassung und Verlaufsuntersuchung von viralen Resistenzen bei Patienten mit fehlendem Ansprechen auf eine Triple-Therapie mit Telaprevir oder Boceprevir in Kombination mit PEG-Interferon Alfa und Ribavirin.
Period: 2014-2015

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. (Study Protocol: TMC435HPC3001)
Phase III
Period: 2011-2014
EudraCT-Nr.: 2011-001180-53

Hepatitis C / HIV

BI 201335: Safety and Efficacy of 120mg and 240mg once daily in combination with pegylated interferon alpha 2a and ribavirin for treatment of chronic Hepatitis C (HCV) genotype 1 infection in HIV/HCV. (Study protocol: BI1220.19)
Period: 2011-2013
EudraCT-Nr.: 2010-021734-59

Sofosbuvir: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). (Study Protocol: GS-US-334-0124 (PHOTON2))
Period: 2013-2014
EudraCT-Nr.: 2012-004154-28