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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ribavirin
Peginterferon alfa 2b
Sponsored by
FGK Clinical Research GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Chronic HCV infection, Genotype 1, Individually adapted therapy, Peginterferon alfa-2b, Ribavirin, Sustained viral response (SVR)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Universitätsklinik Freiburg
  • Universitätsklinik Heidelberg
  • Universitätsklinikum Ulm
  • Uniklinikum Erlangen
  • Klinikum Großhadern
  • Technische Universität München
  • Klinikum der Universität Würzburg
  • Klinikum der J.W.-Goethe-Universität
  • Praxis für Innere Medizin
  • Medizinische Hochschule Hannover
  • St. Josef-Hospital
  • Gemeinschaftspraxis
  • Medizinische Universitäts-Klinik Essen
  • Universität zu Köln
  • Universitätsklinikum Aachen
  • Universitätsklinikum der J. Gutenberg Universität
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Leipzig
  • Christian-Albrechts-Universität zu Kiel
  • Hepatologische Schwerpunktpraxis
  • Charité, Campus Virchow-Klinikum
  • Universitätsklinikum Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Individualized therapy

Historical control

Arm Description

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

48 week standard therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 11, 2006
Last Updated
February 5, 2010
Sponsor
FGK Clinical Research GmbH
Collaborators
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT00351403
Brief Title
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
FGK Clinical Research GmbH
Collaborators
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Chronic HCV infection, Genotype 1, Individually adapted therapy, Peginterferon alfa-2b, Ribavirin, Sustained viral response (SVR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individualized therapy
Arm Type
Experimental
Arm Description
Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.
Arm Title
Historical control
Arm Type
Other
Arm Description
48 week standard therapy
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Rebetol 200 mg: applied as hard capsule
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa 2b
Intervention Description
PegIntron (50/80/100/120/150 microgram): applied by injection
Primary Outcome Measure Information:
Title
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Sarrazin, MD, PhD
Organizational Affiliation
University Hospital, Saarland
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Universitätsklinik Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinik Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Uniklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91056
Country
Germany
Facility Name
Klinikum Großhadern
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Technische Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum der Universität Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Klinikum der J.W.-Goethe-Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Praxis für Innere Medizin
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Dusseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40237
Country
Germany
Facility Name
Medizinische Universitäts-Klinik Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universität zu Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
Facility Name
Universitätsklinikum Aachen
City
Aachen
State/Province
Nordrhein.Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum der J. Gutenberg Universität
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg / Saar
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Christian-Albrechts-Universität zu Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Hepatologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Charité, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21784046
Citation
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.
Results Reference
derived

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

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