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Hepatozelluläres Karzinom


Studienregister CCC München


Primär biliäre Zirrhose (PBC)


BUC-56/PBC

Title: Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis.
Sponsor: Falk Pharma
Brief summary: To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight) plus budesonide (9 mg/d) vs. UDCA and placebo in the treatment of PBC who are at risk for disease progression (aP ≥ 3 ULN or ALT ≥ 2 ULN or bilirubin ≥ 1 mg/dl during UDCA treatment).
Study phase: III
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


URT-15/PBC

Title: Double-blind, double-dummy, randomised, crossover, multicenter phase IV clinical study comparing the effect of Ursofalk 500 mg tablets od versus Ursofalk 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis (PBC).
Sponsor: Falk Pharma
Brief summary: The primary objective of this study is to compare the efficacy of Ursofalk 500 mg tablets (14±2 mg(kg body weight) vs. Ursofalk 250 mg capsules (14±2 mg(kg body weight) in the treatment of PBC (stage I and II). Secondary objectives will be to assess the safety and tolerability in the form of adverse events and laboratory parameters and patients quality of life.
Study phase: IV
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


INT-747-201

Title: A multi-center, randomised, placebo-controlled study of INT-474 (6-ECDCA) monotherapy in patients with primary biliary cirrhosis (PBC).

Sponsor: Intercept Pharmaceuticals
Brief summary: This is a multi-dose, parallel-group study of INT-747 in patients with PBC. Two dose levels (10 and 50 mg) of INT-747 and placebo will be administered orally (PO), daily (QD), for 12 weeks. Screening AP level between 1.5 and 10 × ULN are required. The primary objective is the reduction of aP-levels, secondary endpoints are safety and disease-specific symptoms as assessed by PBC-40 and SF-36.
Study phase: II
Principal investigator: PD Dr. Rust
Status: Einschluß möglich. Kontakt: PD Dr. Rust, Dr. Pusl, Dr. Denk


INT-747-202

Title: A multi-center, randomised, placebo-controlled study of INT-474 (6-ECDCA) in combination with ursodeoxycholic acid in patients with primary biliary cirrhosis (PBC).
Sponsor: Intercept Pharmaceuticals
Brief summary: This is a multi-dose, parallel-group study of INT-747 in patients with PBC. Three dose levels (10, 25 and 50 mg) of INT-747 and placebo will be ad-ministered orally (PO), daily (QD), in combination with UDCA for 12 weeks. The primary objective is the reduction of aP-levels, secondary endpoints are safety and disease-specific symptoms as assessed by PBC-40 and SF-36.
Study phase: II
Principal investigator: PD Dr. Rust
Status: Ongoing, aber Rekrutierung abgeschlossen.


Chronische Hepatitis C


OPTEX 2/3

Titel: 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
Kategorie: A ("Hep-Net geprüft")  &  B ("Hep-Net gefördert")
Brief summary: Patienten mit einer chronischen Hepatitis C und HCV Genotyp 2 oder 3, die eine laufende PegInterferon alfa-2b/Ribavirin-Standardtherapie erhalten und ungünstige Therapievoraussetzungen haben (HCV-RNA > 15 IU/ml an Woche 4 der laufenden Therapie) werden entweder 24 Wochen (Gruppe A) oder 12 Wochen (Gruppe B) mit 1,5 Gg/kg/Woche PegInterferon alpha-2b und 800-1400 mg Ribavirin weiterbehandelt. Beide Gruppen werden nach dem jeweiligen Therapieende 24 Wochen nachbeobachtet. Die Aufteilung auf die 2 Behandlungsoptionen erfolgt per zentraler Randomisierung (1:1). Stratifiziert wird nach Geschlecht, Alter, Genotyp, Zirrhose sowie HCV-RNA Level > 600 000 IU/ml vor Beginn der Standardtherapie
Study phase: Multizentrische, open label, randomisierte Phase IV-Studie
Principal investigator: Prof. Zachoval
Status: Einschluss möglich. Kontakt: Dr. Horster, PD Dr. Grüner, Prof. Zachoval

Vertex ADVANCE


Titel: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C;
Sponsor: Vertex Pharmaceuticals Incorporated, Tibotec, Inc
Brief summary: The advance trial is a double blinded, randomized, phase 3 research study of an investigational drug, Telaprevir (VX-950) or placebo, with peginterferon alfa-2a (Pegasys®), and ribavirin (Copegus®) in people with genotype 1 hepatitis C who have not achieved a sustained viral response (SVR) with a previous treatment of interferon therapy.
Studie: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Protocol-Number: VX07950108
Principal investigator: Prof. Diepolder
Status: Ongoing, aber Rekrutierung abgeschlossen.


ARFI-HCV

Titel: Beurteilung des Leberfibrosestadiums mit der Acoustic Radiation Force Impulse-Imaging imVergleich zur transienten Elastographie bei Patienten mit chronischer Hepatitis C
Studienleitung: Universitätsklinikum Frankfurt
Zusammenfassung: Diagnostikstudie zum Vergleich zweier Ultraschallmethoden zur Bestimmung des Fibrosegrades der Leber. Voraussetzung: Leberbiopsie <1/2 Jahr vor Messung
Studie: Multizentrische, nicht-randomisierte, offene Studie
Principal investigator: Prof. Zachoval
Status: Einschluss laufend möglich. Kontakt: Dr. Horster, Prof. Zachoval


ENABLE 1

Title: Randomized, Placebo-Controlled, multicentre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin)
Sponsor: GSK GmbH und Co.KG
Study phase: III
Principal investigator: Prof. Zachoval
Status: Ongoing, Rekrutierung abgeschlossen. Kontakt: PD Dr. Grüner


ENABLE 2

Title: Randomized, Placebo-Controlled, multicentre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin)
Sponsor: GSK GmbH und Co. KG
Study phase: III
Principal investigator: Prof. Zachoval
Status: Ongoing, Rekrutierung abgeschlossen. Kontakt: PD Dr. Grüner


Akute HCV III Studie

Title: Treatment of acute hepatitis C infection: Immediate therapy of all patients with PEG-Interferon-alfa2b alone versus delayed therapy of patients not eliminating HCV spontaneously with PEG-Interferon-alfa2b plus ribavirin (“acute HCV III study”)
Studienleitung: Medizinische Hochschule Hannover, Kompetenznetz Hepatitis
Study phase: IV
Principal investigator: PD Dr. Grüner
Status: Einschluss möglich. Kontakt: PD Dr. Grüner


GS-US-174 0102

A randomized, double-blind, controlled evaluation of tenofovir DF 300mg QD versus adefovir dipivoxil for the treatment of presumed pre-core mutant hepatitis B
Study phase:
Principal investigator: Prof. Zachoval
Status: Ongoing, Rekrutierung abgeschlossen. Kontakt: PD Dr. Grüner


GS-US-174 0102

A randomized, double-blind, controlled evaluation of tenofovir DF versus adefovir dipivoxil for the treatment of HBeAg positive chronic hepatitis B
Study phase:
Principal investigator: Prof. Zachoval
Status: Ongoing, Rekrutierung abgeschlossen. Kontakt: PD Dr. Grüner


GS-US-174 0106

A phase II, randomised, double-blind study exploring the efficacy, saftey and tolerability of tenofovir disoproxil fumarate (DF) monotherapy versus emtricitabine plus tenofovir DF fixed-dose combination therapy in subjects currently being treated with adefovir dipivoxil for chronic hepatitis B and having persistent viral replication
Study phase: II
Principal investigator: Prof. Zachoval
Status: Ongoing, Rekrutierung abgeschlossen. Kontakt: PD Dr. Grüner


Komplikationen der Leberzirrhose


Erweiterte Diagnostik des Aszites bei Leberzirrhose


Eine multizentrische, nicht randomisierte Studie zur erweiterten Diagnostik bei zirrhotischem Aszites in Hinblick auf spontane bakterielle Peritonitis und Bakteraszites
Studienleitung: Universitätsklinikum Regensburg
Zusammenfassung: Untersuchung der möglichen Rolle verschiedener chemotaktischer Faktoren und Adipokine für das Auftreten und den Verlauf einer Spontan Bakteriellen Peritonitis (SBP) bzw. eines Bakteraszites bei Leberzirrhose
Studie: Multizentrische, nicht-randomisierte, offene Studie
Principal investigator: Prof. Gerbes(GH), PD Dr. Gülberg (INN)
Status: in Vorbereitung, Kontakt: PD Dr. Steib (GH), Dr. Götzberger (INN)


Diastolic dysfunction in cirrhosis

Title: A study into the prevalence of diastolic dysfunction in cirrhosis
Sponsor: No
Brief summary: Cirrhotic cardiomyopathy is not a well recognized condition and the diagnostic criteria are not yet established. The aim of this study is to determine the prevalence of diastolic dysfunction (following the definition criteria provided in this study protocol) in patients with liver cirrhosis and to determine whether other factors (e.g. etiology, severity of liver dysfunction) affect the development of diastolic dysfunction in cirrhosis.
Study phase: Evaluation Study, Mulitcenter.
Principal investigator: Prof. Dr. A. L. Gerbes, Dr. Chr. Steib
Status: Ethikantrag eingereicht. Kontakt: PD Dr. Chr. Steib (GH), PD Dr. V. Gülberg (INN)