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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
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Berlin、ドイツ、13353
- Charité, Campus Virchow-Klinikum
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Berlin、ドイツ、10969
- Hepatologische Schwerpunktpraxis
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Hamburg、ドイツ、20246
- Universitätsklinikum Hamburg-Eppendorf
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Baden-Württemberg
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Freiburg、Baden-Württemberg、ドイツ、79106
- Medizinische Universitätsklinik Freiburg
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Heidelberg、Baden-Württemberg、ドイツ、69120
- Universitätsklinik Heidelberg
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Ulm、Baden-Württemberg、ドイツ、89081
- Universitätsklinikum Ulm
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Bayern
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Erlangen、Bayern、ドイツ、91056
- Uniklinikum Erlangen
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München、Bayern、ドイツ、81675
- Technische Universität München
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München、Bayern、ドイツ、81377
- Klinikum Großhadern
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Würzburg、Bayern、ドイツ、97080
- Klinikum der Universität Würzburg
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Hessen
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Frankfurt、Hessen、ドイツ、60590
- Klinikum der J.W.-Goethe-Universität
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Frankfurt、Hessen、ドイツ、60596
- Praxis für Innere Medizin
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Niedersachsen
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Hannover、Niedersachsen、ドイツ、30625
- Medizinische Hochschule Hannover
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Nordrhein-Westfalen
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Bochum、Nordrhein-Westfalen、ドイツ、44791
- St. Josef-Hospital
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Dusseldorf、Nordrhein-Westfalen、ドイツ、40237
- Gemeinschaftspraxis
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Essen、Nordrhein-Westfalen、ドイツ、45122
- Medizinische Universitäts-Klinik Essen
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Köln、Nordrhein-Westfalen、ドイツ、50924
- Universität zu Köln
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Nordrhein.Westfalen
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Aachen、Nordrhein.Westfalen、ドイツ、52074
- Universitätsklinikum Aachen
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Rheinland-Pfalz
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Mainz、Rheinland-Pfalz、ドイツ、55131
- Universitätsklinikum der J. Gutenberg Universität
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Saarland
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Homburg / Saar、Saarland、ドイツ、66421
- Universitatsklinikum des Saarlandes
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Sachsen
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Leipzig、Sachsen、ドイツ、04103
- Universitätsklinikum Leipzig
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Schleswig-Holstein
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Kiel、Schleswig-Holstein、ドイツ、24105
- Christian-Albrechts-Universität zu Kiel
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Individualized therapy
Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay.
|
Rebetol 200 mg: applied as hard capsule
PegIntron (50/80/100/120/150 microgram): applied by injection
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他の:Historical control
48 week standard therapy
|
Rebetol 200 mg: applied as hard capsule
PegIntron (50/80/100/120/150 microgram): applied by injection
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)
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協力者と研究者
捜査官
- スタディチェア:Christoph Sarrazin, MD, PhD、University Hospital, Saarland
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- INDIV-2
- 2006-000358-38 (EudraCT番号)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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