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Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy
This study is ongoing, but not recruiting participants.
First Received: March 6, 2006   Last Updated: March 8, 2007   History of Changes
Sponsors and Collaborators: Universitätsklinikum Hamburg-Eppendorf
Dr. med Peter Buggisch - University hospital Eppendorf
Hoffmann-La Roche
Information provided by: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00299923
  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 III

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Amantadine sulfate Ribavirin Peginterferon Alfa-2a Amantadine hydrochloride Amantadine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

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

  Show 27 Study Locations
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Dr. med Peter Buggisch - University hospital Eppendorf
Hoffmann-La Roche
Investigators
Principal Investigator: Peter Buggisch, Dr. Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1
  More Information

Additional Information:
No publications provided

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

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
drug therapy
Interferon

Study placed in the following topic categories:
Antimetabolites
Neurotransmitter Agents
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Antiviral Agents
Recurrence
Hepatitis
Virus Diseases
Dopamine
Digestive System Diseases
Analgesics, Non-Narcotic
Peginterferon alfa-2a
Dopamine Agents
Peripheral Nervous System Agents
Analgesics
Hepatitis C
Amantadine
Hepatitis C, Chronic

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

ClinicalTrials.gov processed this record on May 06, 2009