An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
An Exploratory Study to Investigate the Haemodynamic Effects of Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Edinburgh、イギリス、EH16 4TJ
- Novartis Investigative Site
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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:
Study Parts A and B:
-Cirrhosis of alcohol aetiology according to physician's assessment prior to screening.
Part A:
-Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices).
Part B:
- Cirrhosis with TIPSS in situ and PPG>5mmHg.
- Fully functioning TIPSS without variceal filling as confirmed by portography.
Exclusion Criteria:
Study Parts A and B:
- Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
- Decompensated cirrhosis (Child-Pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at visit 1.
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Part A:
- BMI (weight[kg] / height[m^2]) > 40 kg/m^2.
- Any contraindication to having an MRI scan
Part B:
-Contraindication to catheterization
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：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：Part A: Terlipressin acetate
Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
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IV bolus injection
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実験的：Part A: Serelaxin (RLX030)
Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.;
duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
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Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
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実験的：Part B Serelaxin (RLX030)
The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of Portal pressure gradient (PPG) data acquisition.
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Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
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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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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))
時間枠：Baseline, 120 min post serelaxin infusion
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The flow is the average flow over the cardiac cycle.
Total renal artery flow = left renal artery flow + right renal artery flow.
These measurements were collected through magnetic resonance angiography (MRA) scans.
Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
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Baseline, 120 min post serelaxin infusion
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Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)
時間枠：Baseline, 120 min post-infusion start
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Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP). Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion). |
Baseline, 120 min post-infusion start
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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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Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))
時間枠：Baseline, 120 min post infusion
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The flow is the average flow over the cardiac cycle.
Total renal artery flow = left renal artery flow + right renal artery flow.
These measurements were collected through magnetic resonance angiography (MRA) scans.
Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)
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Baseline, 120 min post infusion
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Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))
時間枠：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))
時間枠：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))
時間枠：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))
時間枠：Baseline, 120 min post-infusion
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A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle. Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment). |
Baseline, 120 min post-infusion
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Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)
時間枠：Baseline, 120 min post infusion
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Portal vein pressure was measured at 15 min intervals (i.e.
prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).
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Baseline, 120 min post infusion
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Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin
時間枠：4 weeks
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This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.
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4 weeks
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協力者と研究者
スポンサー
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
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最終確認日
詳しくは
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Terlipressin acetateの臨床試験
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Population Councilわからない
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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator...積極的、募集していない