| 基本情報/Basic information |
| 一般向け試験名/Public title |
ペガシス皮下注90μg/コペガス錠200mg 使用成績調査（C型代償性肝硬変の患者に対する調査）
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Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC |
| 一般向け試験名略称/Acronym |
ペガシス皮下注90μg/コペガス錠200mg 使用成績調査（C型代償性肝硬変の患者に対する調査） |
Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC |
| 科学的試験名/Scientific Title |
ペガシス皮下注90μg/コペガス錠200mg 使用成績調査（C型代償性肝硬変の患者に対する調査）
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Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC |
| 科学的試験名略称/Scientific Title:Acronym |
ペガシス皮下注90μg/コペガス錠200mg 使用成績調査（C型代償性肝硬変の患者に対する調査） |
Prospective observational study on efficacy and safety of PEGASYS/COPEGUS for the treatment of CHC patients with compensated LC |
| 試験実施地域/Region |
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| 介入/Intervention |
| 群数/No. of arms |
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| 介入の目的/Purpose of intervention |
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| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
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| 介入2/Interventions/Control_2 |
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| 介入3/Interventions/Control_3 |
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| 介入4/Interventions/Control_4 |
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| 介入5/Interventions/Control_5 |
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
C型代償性肝硬変と診断された患者
HCVRNAが陽性の患者 |
#Diagnosis of CHC with compensated LC by the investigator
#Positive serum HCV RNA
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| 除外基準/Key exclusion criteria |
最新の添付文書に従う。
主な除外基準
・ショウサイコトウを併用中の患者
・自己免疫性肝炎の患者
・重度の肝機能障害のある患者
・コントロールの困難な心疾患（心筋梗塞、心不全、不整脈等）のある患者
・ペグインターフェロン又はリバビリン又は本剤の成分に対し過敏症の既往歴のある患者
・妊婦、妊娠している可能性のある婦人
・授乳中の婦人
・異常ヘモグロビン症（サラセミア、鎌状赤血球性貧血等）の患者
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All contraindications specified in the Japanese package insert of PEGASYS/COPEGUS must be adhered.
The major exclusion criteria are:
#Coadministration of Shosaikoto
#Autoimmune hepatitis
#Severe hepatic dysfunction
#Unstable or uncontrolled cardiac disease
#Hypersensitivity to peginterferon or ribavirin or to any of the excipients
#Pregnancy (A pregnancy needs to be reliably ruled out before treatment initiation and reliably prevented during treatment, please see the Japanese package insert for PEGASYS/COPEGUS for further details)
#Breast-feeding women
#Hemoglobinopathies (e.g. thalassemia, sickle-cell anemia)
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| 目標参加者数/Target sample size |
500 |
| 結果/Result |
| 結果掲載URL/URL related to results and publications |
Not opened |
| 組み入れ参加者数/Number of participants that the trial has enrolled |
487 |
| 主な結果/Results |
調査票回収症例数494例のうち安全性解析対象除外症例7例を除いた487例を安全性解析対象症例とした。安全性解析対象症例487例より有効性解析対象除外症例95例を除いた392例を有効性解析対象症例とした。 |
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis. |
| 主な結果入力日/Results date posted |
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| 結果掲載遅延/Results Delayed |
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| 結果遅延理由/Results Delay Reason |
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| 最初の試験結果の出版日/Date of the first journal publication of results |
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| 参加者背景/Baseline Characteristics |
安全性解析対象症例487例の患者背景において，性別は「男性」56.46 %（275/487例），「女性」43.53 %（212/487例）で，年齢の中央値は63.0歳（最小26歳，最大81歳）で，65歳以上の症例が44.76 %（218/487例）であった。 |
The 487 patients in the safety analysis set had the following baseline characteristics. The patients were 56.46% (275/487) male and 43.53% (212/487) female. |
| 参加者の流れ/Participant flow |
調査票回収症例数494例のうち安全性解析対象除外症例7例を除いた487例を安全性解析対象症例とした。安全性解析対象症例487例より有効性解析対象除外症例95例を除いた392例を有効性解析対象症例とした。 |
The safety analysis set included 487 of the 494 patients for whom case report forms were collected. This excluded 7 patients who were excluded from the safety analysis. The efficacy analysis set included 392 of the 487 patients in the safety analysis set. This excluded 95 patients who were excluded from the efficacy analysis. |
| 有害事象/Adverse events |
安全性解析対象症例487例の副作用発現症例率は74.94 %（365/487例），発現件数は1036件であった。投与期間，観察期間，患者背景等が異なるため直接比較は困難であるが承認時までの副作用発現症例率100.00 %（61/61例）に対し，本調査での副作用発現症例率は低かった。 |
The incidence of adverse drug reactions (ADRs) in the 487 patients in the safety analysis set was 74.94% (365/487 patients), with 1036 events reported. Although differences in treatment duration, length of observation, and patient baseline characteristics prevent a direct comparison, the incidence of ADRs in the surveillance study was lower than that prior to approval (100.00%, 61/61 patients). |
| 評価項目/Outcome measures |
セロタイプ1型・高ウイルス量群の有効性解析対象症例200例のうちSVR率が評価可能であった180例における，投与終了後24週時のSVR率は，16.66 %（30/180例）であった。また，生化学的効果が評価可能であった162例における，投与終了後24週時のALT正常化率（30 IU/L）は，43.82 %（71/162例）であった。 |
The sustained virological response (SVR) rate 24 weeks after treatment completion was 16.66% (30/180) in the 180 patients evaluable for SVR rate from the 200 patients in the serotype 1/high viral load group of the efficacy analysis set. The ALT normalization rate (30 IU/L) 24 weeks after treatment completion was 43.82% (71/162) in the 162 patients evaluable for biological response. |
| 個別症例データ共有計画/Plan to share IPD |
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| 個別症例データ共有計画の詳細/IPD sharing Plan description |
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| その他/Other |
| その他関連情報/Other related information |
以下の有効性の検討
SVR，end of treatment response，ALT正常化率
また，上記の有効性評価項目についてジェノタイプ別，ウイルス量別効果
フォローアップ期間（2014年まで）における肝疾患進行（非代償期への移行，肝細胞癌発癌）の確認
有効性・安全性に影響を及ぼす因子の確認
ウイルス学的効果，SVR，再燃に影響を及ぼすウイルス，宿主，治療に関連する因子（年齢，体重,性別，投与前ウイルス量，ALT値，肝線維化ステージ，治療中のウイルス学的効果，薬剤暴露）の確認，同定
ジェノタイプ別ペガシス/リバビリン累積投与量とSVRの関連
血液学的検査頻度の確認
減量・休薬の頻度，理由の確認 |
To assess the following efficacy
- SVR, end of treatment response, ALT normalization rate
- Above efficacy variables by HCV genotype and viral load
To confirm advanced liver disease (decompensated LC, development of HCC ) during follow up (by June 2014)
To assess factors influencing efficacy and safety
Identification and confirmation of host-, virus- and treatment-related factors (e.g. age, body weight, gender, pre-treatment viral load, ALT ratio, liver fibrosis stage, on-treatment response and treatment exposure) influencing virological response, SVR and relapse
Correlation between overall treatment duration after HCV RNA becomes negative and SVR by genotype
Correlation of cumulative ribavirin and cumulative peginterferon dose with SVR by genotype.
To confirm frequency of hematological test
To confirm frequency and reason for dose modification
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