Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection

NCT00351403 | Completed Phase 4

• 2 other identifiers: INDIV-22006-000358-38
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Keywords

Chronic HCV infection; Genotype 1; Individually adapted therapy; Peginterferon alfa-2b; Ribavirin; Sustained viral response (SVR)

Outcome Measures

Primary Outcomes (1)

• Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)

Study Arms (2)

Individualized therapy

EXPERIMENTAL

Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.

Drug: Ribavirin; Drug: Peginterferon alfa 2b

Historical control

OTHER

48 week standard therapy

Drug: Ribavirin; Drug: Peginterferon alfa 2b

Interventions

Ribavirin DRUG

Rebetol 200 mg: applied as hard capsule

Historical control; Individualized therapy

Peginterferon alfa 2b DRUG

PegIntron (50/80/100/120/150 microgram): applied by injection

Historical control; Individualized therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• FGK Clinical Research GmbH: lead
• University Hospital, Saarland: collaborator

Study Sites (22)

Medizinische Universitätsklinik Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinik Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Uniklinikum Erlangen

Erlangen, Bavaria, 91056, Germany

Location

Klinikum Großhadern

München, Bavaria, 81377, Germany

Location

Technische Universität München

München, Bavaria, 81675, Germany

Location

Klinikum der Universität Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Klinikum der J.W.-Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

Location

Praxis für Innere Medizin

Frankfurt am Main, Hesse, 60596, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Aachen

Aachen, Nordrhein.Westfalen, 52074, Germany

Location

St. Josef-Hospital

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Universität zu Köln

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Gemeinschaftspraxis

Düsseldorf, North Rhine-Westphalia, 40237, Germany

Location

Medizinische Universitäts-Klinik Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Universitätsklinikum der J. Gutenberg Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum des Saarlandes

Homburg / Saar, Saarland, 66421, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Christian-Albrechts-Universität zu Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Hepatologische Schwerpunktpraxis

Berlin, State of Berlin, 10969, Germany

Location

Charité, Campus Virchow-Klinikum

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

• Sarrazin C, Schwendy S, Moller B, Dikopoulos N, Buggisch P, Encke J, Teuber G, Goeser T, Thimme R, Klinker H, Boecher WO, Schulte-Frohlinde E, Prinzing R, Herrmann E, Zeuzem S, Berg T. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22.

  PMID: 21784046 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Christoph Sarrazin, MD, PhD

  University Hospital, Saarland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 8, 2010

Record last verified: 2010-02

Locations

DE (22)