DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) (DARE-C II)
An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment.
The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.
調査の概要
詳細な説明
To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.
An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12
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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New South Wales
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Sydney、New South Wales、オーストラリア、2010
- St Vincent's Hospital
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Royal Adelaide Hospital
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Victoria
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Melbourne、Victoria、オーストラリア、3050
- Royal Melbourne Hospital
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Melbourne、Victoria、オーストラリア、3004
- Alfred Hospital
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-
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Grafton
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Auckland、Grafton、ニュージーランド、1023
- Auckland City Hospital
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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:
- Provision of written informed consent
- Male and female patients aged 18 years and above
- Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
- HBsAg negative
- Detectable HCV RNA at screening (>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
- Compensated liver disease (Child-Pugh A)
- Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
- Medically stable on the basis of physical examination, medical history and vital signs
- Adequate English to provide reliable responses to the study questionnaires
- Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
If co-infection with HIV is documented, the subject must meet the following criteria:
- Antiretroviral (ARV) untreated for >8 weeks preceding screening visit with CD4 T cell count >500 cells/mm3 OR
- On a stable ARV regimen for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and an undetectable plasma HIV RNA level.
Exclusion Criteria:
- Standard exclusions to RBV therapy
- Pregnancy/lactation or male subjects whose female partners are pregnant
- Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin <3.3 g/dL; Serum total bilirubin >1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Sofosbuvir and ribavirin
Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg <75 kg, 1200mg >/= 75kg) daily Treatment will be for 6 weeks in all participants. |
Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
他の名前：
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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 |
|---|---|---|
|
SVR 12
時間枠：12 weeks post treatment
|
Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)
|
12 weeks post treatment
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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 |
|---|---|---|
|
SVR 24
時間枠：24 weeks post treatment
|
Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)
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24 weeks post treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
End of treatment response
時間枠：End of treatment week 6
|
Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6)
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End of treatment week 6
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SVR 4
時間枠：4 weeks post treatment
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Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10)
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4 weeks post treatment
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Follow up 1 year
時間枠：1 year post treatment
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Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58)
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1 year post treatment
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Undetectable HCV RNA
時間枠：Week 1, 2, 3 and 4 of treatment
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Proportion of patients with undetectable HCV RNA at weeks 1, 2, 3 and 4
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Week 1, 2, 3 and 4 of treatment
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Indicators of toxicity (ALT, HB, Neutrophils, Platelets)
時間枠：Baseline until week 4 of treatment
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To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy
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Baseline until week 4 of treatment
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Plasma ribavirin levels and haemoglobin
時間枠：Baseline to week 4 of treatment
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To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
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Baseline to week 4 of treatment
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Incidence of reinfection
時間枠：End of treatment until follow up 1 year
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Incidence of reinfection after documented SVR
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End of treatment until follow up 1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gail Matthews, MbChB FRACP、Kirby Institute
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- VHCRP1206
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