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Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

Primary Purpose

Hepatitis C, Chronic, Relapse

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Peginterferon alfa-2a, Ribavirin, Amantadine
Sponsored by
University of Hamburg-Eppendorf
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring drug therapy, Interferon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Relapsers to previous combination therapy with (PEG-)IFN alfa-/Ribavirin and a negative HCV-RNA test result at the end of this regular treatment course and positive HCV-RNA test result during the follow-up period. Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment Chronic HCV infection genotype 1 or 3. Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU) Compensated liver disease (Child-Pugh A) Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done Negative urine or blood pregnancy test All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment Exclusion Criteria (at screening): Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs Ongoing pregnancy or breast feeding Male partners of women who are pregnant or with women without effective contraception Signs or symptoms of hepatocellular carcinoma Chronic HCV infection genotype 2, 4, 5 or 6 Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded. Any investigational drug < 6 weeks prior to the first dose of study drug Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV History or other evidence of a medical condition associated with chronic liver disease other than HCV History or other evidence of decompensated liver disease or a Child-Pugh score > 6. Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3 Serum creatinin concentration >1.5 mg/dl History of severe psychiatric disease, especially depression. History of a severe seizure disorder that can not be stabilized by medication History of immunologically mediated disease Chronic pulmonary disease associated with functional limitation History of severe cardiac disease History of major organ transplantation except corneatransplantation Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Thyroid dysfunction not adequately controlled Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution Take of Memantine during study period Cardiomyopathy and myocarditis AV-Block II° and III° Pre-existing bradycardia < 55 counts/min Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome History of severe ventricular arrhythmia incl. Torsade de pointes Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics) Patients with obstructive glaucoma Patients with excitableness and confusion Patients with delirium and exogenic psychosis in the anamnesis Prostataadenome Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide Inability or unwillingness to provide informed consent or abide by the requirements of the study

Sites / Locations

  • Universitätsklinikum Mannheim
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Freiburg
  • Universitätsklinikum Ulm
  • Universitätsklinikum Erlangen
  • Klinikum rechts der Isar der TU München
  • Krankenhaus Barmherzige Brüder
  • Klinikum der Universität Regensburg
  • Klinikum der Universität Würzburg
  • J. W.-Goethe-Universität
  • Universität Rostock
  • Medizinische Hochschule Hannover
  • Klinikum der Ruhr-Universität Bochum
  • Universitätsklinikum Bonn
  • Klinikum der Universität Köln
  • Universitätsklinkum Münster
  • St-Josef-Hospital
  • Johannes Gutenberg-Universität Mainz
  • Universitätsklinikum des Saarlandes
  • Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg
  • Universitätsklinikum Schleswig-Holstein
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Praxis Möller/ Heyne
  • Charité, Campus Benjamin Franklin
  • Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie)
  • Klinikum Bremen-Mitte
  • Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1

Outcomes

Primary Outcome Measures

- Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks.

Secondary Outcome Measures

relationship between EVR during the first twelve weeks and SVR
virological response to the combination of standard dose defined as reduction of HCV RNA at week 4, 12, 24, 48 and 72 of treatment, separated between HCV-Genotypes.

Full Information

First Posted
March 6, 2006
Last Updated
March 8, 2007
Sponsor
University of Hamburg-Eppendorf
Collaborators
Universitätsklinikum Hamburg-Eppendorf, Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00299923
Brief Title
Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy
Official Title
Randomized, Open-Label, Multicenter Study Examining the Effects of Duration of Treatment of PEGASYS® in Combination With Daily COPEGUS® + Amantadine in Patients With Chronic HCV After Relapse to Previous (Peg)IFN + Ribavirin Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Hamburg-Eppendorf
Collaborators
Universitätsklinikum Hamburg-Eppendorf, Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, Relapse
Keywords
drug therapy, Interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a, Ribavirin, Amantadine
Primary Outcome Measure Information:
Title
- Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks.
Secondary Outcome Measure Information:
Title
relationship between EVR during the first twelve weeks and SVR
Title
virological response to the combination of standard dose defined as reduction of HCV RNA at week 4, 12, 24, 48 and 72 of treatment, separated between HCV-Genotypes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Relapsers to previous combination therapy with (PEG-)IFN alfa-/Ribavirin and a negative HCV-RNA test result at the end of this regular treatment course and positive HCV-RNA test result during the follow-up period. Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment Chronic HCV infection genotype 1 or 3. Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU) Compensated liver disease (Child-Pugh A) Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done Negative urine or blood pregnancy test All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment Exclusion Criteria (at screening): Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs Ongoing pregnancy or breast feeding Male partners of women who are pregnant or with women without effective contraception Signs or symptoms of hepatocellular carcinoma Chronic HCV infection genotype 2, 4, 5 or 6 Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded. Any investigational drug < 6 weeks prior to the first dose of study drug Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV History or other evidence of a medical condition associated with chronic liver disease other than HCV History or other evidence of decompensated liver disease or a Child-Pugh score > 6. Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3 Serum creatinin concentration >1.5 mg/dl History of severe psychiatric disease, especially depression. History of a severe seizure disorder that can not be stabilized by medication History of immunologically mediated disease Chronic pulmonary disease associated with functional limitation History of severe cardiac disease History of major organ transplantation except corneatransplantation Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Thyroid dysfunction not adequately controlled Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution Take of Memantine during study period Cardiomyopathy and myocarditis AV-Block II° and III° Pre-existing bradycardia < 55 counts/min Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome History of severe ventricular arrhythmia incl. Torsade de pointes Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics) Patients with obstructive glaucoma Patients with excitableness and confusion Patients with delirium and exogenic psychosis in the anamnesis Prostataadenome Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide Inability or unwillingness to provide informed consent or abide by the requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Buggisch, Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
State/Province
Baden-Würtemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württembeg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93049
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Klinikum der Universität Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
J. W.-Goethe-Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universität Rostock
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
23538
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum der Ruhr-Universität Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Klinikum der Universität Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
Facility Name
Universitätsklinkum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
St-Josef-Hospital
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46045
Country
Germany
Facility Name
Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Bad Homburg/ Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Praxis Möller/ Heyne
City
Berlin
ZIP/Postal Code
10696
Country
Germany
Facility Name
Charité, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

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