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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00351403
• Other study ID #: INDIV-2
• Secondary ID: 2006-000358-38
• Status: Completed
• Phase: Phase 4
• First received: July 11, 2006
• Last updated: February 5, 2010
• Start date: July 2006
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: FGK Clinical Research GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ribavirin
Rebetol 200 mg: applied as hard capsule
• Peginterferon alfa 2b
PegIntron (50/80/100/120/150 microgram): applied by injection

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen	Nordrhein.Westfalen
Germany	Charité, Campus Virchow-Klinikum	Berlin
Germany	Hepatologische Schwerpunktpraxis	Berlin
Germany	St. Josef-Hospital	Bochum	Nordrhein-Westfalen
Germany	Gemeinschaftspraxis	Dusseldorf	Nordrhein-Westfalen
Germany	Uniklinikum Erlangen	Erlangen	Bayern
Germany	Medizinische Universitäts-Klinik Essen	Essen	Nordrhein-Westfalen
Germany	Klinikum der J.W.-Goethe-Universität	Frankfurt	Hessen
Germany	Praxis für Innere Medizin	Frankfurt	Hessen
Germany	Medizinische Universitätsklinik Freiburg	Freiburg	Baden-Württemberg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitätsklinik Heidelberg	Heidelberg	Baden-Württemberg
Germany	Universitätsklinikum des Saarlandes	Homburg / Saar	Saarland
Germany	Christian-Albrechts-Universität zu Kiel	Kiel	Schleswig-Holstein
Germany	Universität zu Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitätsklinikum der J. Gutenberg Universität	Mainz	Rheinland-Pfalz
Germany	Klinikum Großhadern	München	Bayern
Germany	Technische Universität München	München	Bayern
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Germany	Klinikum der Universität Würzburg	Würzburg	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
FGK Clinical Research GmbH	University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)