Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
2015年9月24日 更新者:Cheng jun、Beijing Kawin Technology Share-Holding Co., Ltd.
Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C
This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin(RBV) in the treatment of Chronic hepatitis C who have not been previously treated with Interferon.
調査の概要
詳細な説明
Total 720 subjects are divided into two groups and treated separately according to the HCV genotype(genotype 2,3 and non-genotype 2,3).
With 2:1 ratio between experimental group and positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled.
Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .
研究の種類
介入
入学 (実際)
719
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing、中国
- Peking University first hospital
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Beijing、中国
- Beijing Ditan Hospital, Capital Medical University
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Beijing、中国
- Beijing Youan Hospital, Capital Medical University
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Beijing、中国
- Peking University People's Hospital
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Beijing、中国
- 302 Military Hospital of China
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Beijing、中国
- Beijing Youyi Hospital, capital Medical University
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Beijing、中国
- General Hospital of Beijing Military Region
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Chongqing、中国
- The Second Affiliated Hospital of Chongqing Medical University
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Chongqing、中国
- Chongqing Southwest Hospital
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Shanghai、中国
- Shanghai Public Health Clinical Center
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Tianjin、中国
- Tianjin Infectious Disease Hospital
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Gansu
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Lanzhou、Gansu、中国
- First Affiliated Hospital of Lanzhou University
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Guangdong
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Guangzhou、Guangdong、中国
- Guangzhou Eighth People's Hospital
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Guangzhou、Guangdong、中国
- Nanfang Hospital Southern Medical Unbiversity
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Guangxi
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Nanning、Guangxi、中国
- The First Affiliated Hospital of Guangxi Medical University
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Hebei
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Shijiazhuang、Hebei、中国
- Third Affiliated Hospital, Hebei Medical University
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Heilongjiang
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Harbin、Heilongjiang、中国
- The Second Affiliated Hospital of Harbin Medical University
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Henan
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Xinxiang、Henan、中国
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou、Henan、中国
- Henan Provincial People's Hospital
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Hubei
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Wuhan、Hubei、中国
- Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
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Wuhan、Hubei、中国
- Zhongnan Hospital of Wuhan University
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Wuhan、Hubei、中国
- Union hospital, Tongji Medical College Huazhong University of Science & Technology
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Hunan
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Changsha、Hunan、中国
- The Second Xiangya Hospital Of Central South University
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Changsha、Hunan、中国
- Xiangya Hospital Central-South University
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Jiangsu
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Nanjing、Jiangsu、中国
- Jiangsu Province Hospital
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Nanjing、Jiangsu、中国
- The Second Hospital of Nanjing
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Jiangxi
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Nanchang、Jiangxi、中国
- First Affiliated Hospital of Nanchang University
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Jilin
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Changchun、Jilin、中国
- The First Affiliated Hospital of Jilin University
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Yanji、Jilin、中国
- Yanbian University Hospital (Yanbian Hospital)
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Liaoning
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Shenyang、Liaoning、中国
- The Sixth People's Hospital of Shenyang
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Shaanxi
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Xi'an、Shaanxi、中国
- First Affiliated Hospital Of Medical College of Xian Jiaotong University
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Xi'an、Shaanxi、中国
- Second Affiliated Hospital Of Medical College of Xian Jiaotong University
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Xi'an、Shaanxi、中国
- Tangdu hospital,fourth military medical university
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Shandong
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Jinan、Shandong、中国
- Qilu Hospital Of Shandong University
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Jinan、Shandong、中国
- Jinan Infectious Disease Hospital
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Qingdao、Shandong、中国
- Qingdao Municipal Hospital
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Shanxi
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Taiyuan、Shanxi、中国
- The First Hospital of Shanxi Medical University
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Sichuan
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Chengdu、Sichuan、中国
- West China Hospital, Sichuan University
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Chengdu、Sichuan、中国
- Sichuan Academy of Medical Science &Sichuan Provincial People's Hospital
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Xinjiang
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Urumqi、Xinjiang、中国
- The First Teaching Hospital of Xinjiang Medical University
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Zhejiang
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Wenzhou、Zhejiang、中国
- The First Affiliated Hospital of Wenzhou Medical University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age 18- 65 years
- Body Mass Index (BMI) 18-30
- Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
- Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
- Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
- Volunteered to participate in this study, understood and signed an informed consent
Exclusion Criteria:
- Previous IFN treated patients
- Hepatotoxic drugs was systematically used more than two weeks within past 6 months
- Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
- Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
- Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
- Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP> l00ng/ml, suspicious liver nodules by imaging examinations
- Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
- White blood cell count <3×109/L; Neutrophil count<1.5×109/L; platelet count<90×109/L; hemoglobin below the lower limit of normal
- Serum creatinine above the ULN
- Serum creatine kinase> 3 ULN
- Diabetes mellitus or Poorly controlled Thyroid Diseases
- Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions
- Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
- Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
- Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
- Serious blood disorders (all kinds of anemia, hemophilia, etc.)
- Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
- Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
- Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
- Malignancies
- Function organs transplant
- Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
- Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day)
- Pregnant or lactating women
- Usage of prohibition drugs in this study
- Participated in other clinical trials 3 months prior to the screening
- Unwilling to sign the informed consent and adhere to treatment requirements
- Other conditions not suitable for study judged by investigators
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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: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:PEG-IFN-SA /RBV T1(Genotype2,3)
PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid(BW<75kg,1000mg/d; BW≥75kg, 1200mg/d),24 weeks
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アクティブコンパレータ:Pegasys /RBV C1(Genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 24 weeks
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実験的:PEG-IFN-SA /RBV T2(Non-genotype 2,3)
PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 48 weeks
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アクティブコンパレータ:Pegasys /RBV C2(Non-genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),(BW<75kg,1000mg/d;BW≥75kg,1200mg/d)for 48 weeks
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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 |
メジャーの説明 |
時間枠 |
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SVR (sustained virologic response)
時間枠:24 weeks after 24 or 48 weeks of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment
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24 weeks after 24 or 48 weeks of study therapy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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RVR(rapid virologic response)
時間枠:weeks 4 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4
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weeks 4 of study therapy
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cEVR (complete early virologic response)
時間枠:weeks 12 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12
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weeks 12 of study therapy
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ETVR( end of treatment virologic response)
時間枠:weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment
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weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3
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eRVR ( extended rapid virologic response)
時間枠:weeks 4 and 12 of study therapy
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defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12
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weeks 4 and 12 of study therapy
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No-responses
時間枠:weeks 12 or weeks 24 of study therapy
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defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24
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weeks 12 or weeks 24 of study therapy
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Breakthrough
時間枠:weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
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defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)
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weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3
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Relapse
時間枠:12 and 24 weeks after 24 or 48 weeks of study therapy
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defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then
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12 and 24 weeks after 24 or 48 weeks of study therapy
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Cheng jun, MD, PhD、Beijing Ditan Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年6月1日
一次修了 (実際)
2015年8月1日
研究の完了 (実際)
2015年8月1日
試験登録日
最初に提出
2013年7月17日
QC基準を満たした最初の提出物
2013年7月17日
最初の投稿 (見積もり)
2013年7月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年9月25日
QC基準を満たした最後の更新が送信されました
2015年9月24日
最終確認日
2015年9月1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
- KAWIN-002-2
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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