- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00351403
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity.
The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Further objectives of this trial are:
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.
To evaluate the biochemical response to the treatment (ALT values during and after the therapy) in comparison to the virological response to the treatment.
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.
To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Berlin, Duitsland, 13353
- Charité, Campus Virchow-Klinikum
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Berlin, Duitsland, 10969
- Hepatologische Schwerpunktpraxis
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Hamburg, Duitsland, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Duitsland, 79106
- Medizinische Universitätsklinik Freiburg
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Heidelberg, Baden-Württemberg, Duitsland, 69120
- Universitätsklinik Heidelberg
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Ulm, Baden-Württemberg, Duitsland, 89081
- Universitatsklinikum Ulm
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Bayern
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Erlangen, Bayern, Duitsland, 91056
- Uniklinikum Erlangen
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München, Bayern, Duitsland, 81675
- Technische Universität München
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München, Bayern, Duitsland, 81377
- Klinikum Großhadern
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Würzburg, Bayern, Duitsland, 97080
- Klinikum der Universität Würzburg
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Hessen
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Frankfurt, Hessen, Duitsland, 60590
- Klinikum der J.W.-Goethe-Universität
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Frankfurt, Hessen, Duitsland, 60596
- Praxis für Innere Medizin
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Niedersachsen
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Hannover, Niedersachsen, Duitsland, 30625
- Medizinische Hochschule Hannover
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Duitsland, 44791
- St. Josef-Hospital
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Dusseldorf, Nordrhein-Westfalen, Duitsland, 40237
- Gemeinschaftspraxis
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Essen, Nordrhein-Westfalen, Duitsland, 45122
- Medizinische Universitäts-Klinik Essen
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Köln, Nordrhein-Westfalen, Duitsland, 50924
- Universität zu Köln
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Nordrhein.Westfalen
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Aachen, Nordrhein.Westfalen, Duitsland, 52074
- Universitätsklinikum Aachen
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Duitsland, 55131
- Universitätsklinikum der J. Gutenberg Universität
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Saarland
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Homburg / Saar, Saarland, Duitsland, 66421
- Universitätsklinikum des Saarlandes
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Sachsen
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Leipzig, Sachsen, Duitsland, 04103
- Universitätsklinikum Leipzig
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Duitsland, 24105
- Christian-Albrechts-Universität zu Kiel
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
- Presence of a HCV genotype 1 infection
- Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value >= 13 g/dl in men, >= 12 g/dl in women - Leukocytes >= 3.000/mm3 or neutrophile granulocytes > 1.500/mm3 - Thrombocytes > 80.000/mm3
- Total bilirubin in the normal range
- Albumin in the normal range
- Serum creatinine in the normal range THS in the normal range
- Exclusion of an autoimmune hepatitis
- Alpha-Fetoprotein in the normal range
- Negative HIV test
- Negativity of Hepatitis B surface antigens (Hbs-Ag)
- Normal or elevated ALT/GTP values at screening
- At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
- Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
- A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and 6 (women) to 7 (men) months after the therapy
Exclusion Criteria:
- Age < 18 years, > 70 years
- Previous treatment of hepatitis c with (Peg)Interferon alfa or (Peg)Interferon alfa/Ribavirin
- Patients with organ transplantations other than cornea or hair
- Infection with HCV genotype 2,3,4,5 or 6
- Pregnant or nursing women
- Any other reason for the liver disease than chronic hepatitis C
- Suspected hypersensitivity to Interferon, Peginterferon or Ribavirin
- Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study
- Patients with any kind of hemoglobinopathy
- Documented liver disease in advanced state Liver cirrhosis Child B and C
- Each known and existing clinical conditions that might challenge the participation or completion of this clinical trial as depressions, psychosis, severe psychiatric diseases, suicide ideations CNS traumata or cramps which need medicamentous treatment
- Relevant cardiovascular dysfunctions in the last 6 months or patients with clinically relevant changes in the ECG
- Insufficiently adjusted diabetes mellitus
- Severe chronic lung diseases (as e.g. COPD)
- Immunologic diseases or autoimmune-diseases or any other disease which demand a longtime treatment with corticosteroids during this clinical trial
- Clinically relevant gout
- Abuse of drugs, alcohol or pharmaceuticals
- Patient with clinically relevant changes of the retina
- Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Individualized therapy
Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.
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Rebetol 200 mg: applied as hard capsule
PegIntron (50/80/100/120/150 microgram): applied by injection
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Ander: Historical control
48 week standard therapy
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Rebetol 200 mg: applied as hard capsule
PegIntron (50/80/100/120/150 microgram): applied by injection
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Christoph Sarrazin, MD, PhD, University Hospital, Saarland
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Enterovirusinfecties
- Picornaviridae-infecties
- Hepatitis, chronisch
- Infecties
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, chronisch
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Antimetabolieten
- Ribavirine
- Peginterferon alfa-2b
Andere studie-ID-nummers
- INDIV-2
- 2006-000358-38 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hepatitis C, chronisch
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Tripep ABInovio PharmaceuticalsOnbekendChronische hepatitis C-virusinfectieZweden
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Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C virale infectieVerenigde Staten, Nieuw-Zeeland
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Trek Therapeutics, PBCVoltooidChronische Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C virale infectieVerenigde Staten
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Hadassah Medical OrganizationOnbekendChronische hepatitis C-virusinfectieIsraël
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AbbVieVoltooidHepatitis C-virus | Chronisch hepatitis C-virus
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Beni-Suef UniversityVoltooidChronische hepatitis C-virusinfectieEgypte
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University Health Network, TorontoVoltooidChronische hepatitis C-infectieCanada
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Klinische onderzoeken op Ribavirin
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Children's Hospital of Fudan UniversityWeihai Rensheng PharmacyVoltooid
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Prof. Facchinetti FabioMerck Sharp & Dohme LLCVoltooid
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University of Colorado, DenverJanssen Scientific Affairs, LLCBeëindigdHepatitis CVerenigde Staten
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Azienda Ospedaliera San Camillo ForlaniniVoltooid
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Baqiyatallah Medical Sciences UniversityShahid Beheshti University of Medical Sciences; Guilan University of Medical... en andere medewerkersVoltooidHemofilie | Hepatitis CIran, Islamitische Republiek
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Baqiyatallah Medical Sciences UniversityGuilan University of Medical Sciences; Baqiyatallah Research Center for Gastroenterology... en andere medewerkersVoltooidHepatitis C | ThalassemieIran, Islamitische Republiek
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Mashhad University of Medical SciencesVoltooidChronische Hepatitis CIran, Islamitische Republiek
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Xi'an International Medical Center HospitalVoltooid