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Hepatitis C, ChronicPhase 3NCT00299923

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

A Phase 3 study testing Peginterferon alfa-2a, Ribavirin, Amantadine in people with Hepatitis C, Chronic and Relapse, run by University of Hamburg-Eppendorf at 27 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic, Relapse
What is being tested?
Peginterferon alfa-2a, Ribavirin, Amantadine
How many people
300 participants
Where
27 sitesGermany
Study dates
Nov 2005to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites

  • Universitätsklinikum des Saarlandes

    Bad Homburg/ Saar, Saarland, 66421

  • Praxis Möller/ Heyne

    Berlin, State of Berlin, 10696

  • Charité, Campus Benjamin Franklin

    Berlin, State of Berlin, 12203

  • Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie)

    Berlin, 13353

  • Klinikum der Ruhr-Universität Bochum

    Bochum, North Rhine-Westphalia, 44791

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Klinikum Bremen-Mitte

    Bremen, Free Hanseatic City of Bremen, 28205

  • Klinikum der Universität Köln

    Cologne, North Rhine-Westphalia, 50931

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • J. W.-Goethe-Universität

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg

    Halle, Saxony-Anhalt, 06120

  • Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Württembeg, 69120

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538

  • Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Mannheim

    Mannheim, Baden-Würtemberg, 68167

  • Klinikum rechts der Isar der TU München

    München, Bavaria, 81675

  • Universitätsklinkum Münster

    Münster, North Rhine-Westphalia, 48149

  • St-Josef-Hospital

    Oberhausen, North Rhine-Westphalia, 46045

  • Krankenhaus Barmherzige Brüder

    Regensburg, Bavaria, 93049

  • Klinikum der Universität Regensburg

    Regensburg, Bavaria, 93053

  • Universität Rostock

    Rostock, Mecklenburg-Vorpommern, 23538

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Klinikum der Universität Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this 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.

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.

Being tested
Peginterferon alfa-2a, Ribavirin, Amantadine
Keywords
drug therapy, Interferon
Medical subject headings
Hepatitis C, Chronic, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peginterferon alfa-2a, Ribavirin, AmantadineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. - 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 outcomes (2)

  1. relationship between EVR during the first twelve weeks and SVR

  2. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2006 (estimated)
  2. Study startNov 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00299923
Sponsor's protocol ID
ML 18545 (TRELA)
Other IDs
EudraCT-Nr.: 2005-001207-19
Status last verified
Mar 2007
First submitted
6 Mar 2006
Last updated
9 Mar 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alfa-2a, Ribavirin, Amantadine in people with Hepatitis C, Chronic and Relapse, run by University of Hamburg-Eppendorf at 27 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

- Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00299923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2007.

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