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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Universitätsklinikum Hamburg-Eppendorf
Hoffmann-La Roche
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00299923
First received: March 6, 2006
Last updated: March 8, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Relapse
Drug: Peginterferon alfa-2a, Ribavirin, Amantadine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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.

Estimated Enrollment: 300
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299923

Locations
Germany
Universitätsklinikum Mannheim
Mannheim, Baden-Würtemberg, Germany, 68167
Universitätsklinikum Heidelberg
Heidelberg, Baden-Württembeg, Germany, 69120
Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89081
Universitätsklinikum Erlangen
Erlangen, Bayern, Germany, 91054
Klinikum rechts der Isar der TU München
München, Bayern, Germany, 81675
Klinikum der Universität Regensburg
Regensburg, Bayern, Germany, 93053
Krankenhaus Barmherzige Brüder
Regensburg, Bayern, Germany, 93049
Klinikum der Universität Würzburg
Würzburg, Bayern, Germany, 97080
J. W.-Goethe-Universität
Frankfurt, Hessen, Germany, 60590
Universität Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 23538
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Klinikum der Ruhr-Universität Bochum
Bochum, Nordrhein-Westfalen, Germany, 44791
Universitätsklinikum Bonn
Bonn, Nordrhein-Westfalen, Germany, 53127
Klinikum der Universität Köln
Köln, Nordrhein-Westfalen, Germany, 50931
Universitätsklinkum Münster
Münster, Nordrhein-Westfalen, Germany, 48149
St-Josef-Hospital
Oberhausen, Nordrhein-Westfalen, Germany, 46045
Johannes Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum des Saarlandes
Bad Homburg/ Saar, Saarland, Germany, 66421
Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Charité, Campus Benjamin Franklin
Berlin, Germany, 12203
Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie)
Berlin, Germany, 13353
Praxis Möller/ Heyne
Berlin, Germany, 10696
Klinikum Bremen-Mitte
Bremen, Germany, 28205
Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1
Hamburg, Germany, 20246
Sponsors and Collaborators
University of Hamburg
Universitätsklinikum Hamburg-Eppendorf
Hoffmann-La Roche
Investigators
Principal Investigator: Peter Buggisch, Dr. Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00299923     History of Changes
Other Study ID Numbers: ML 18545 (TRELA), EudraCT-Nr.: 2005-001207-19
Study First Received: March 6, 2006
Last Updated: March 8, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
drug therapy
Interferon

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Amantadine
Peginterferon alfa-2a
Ribavirin
Analgesics
Analgesics, Non-Narcotic
Anti-Dyskinesia Agents
Anti-Infective Agents
Antimetabolites
Antiparkinson Agents
Antiviral Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014