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

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).

Gesamtstatus Completed
Anfangsdatum April 2013
Fertigstellungstermin December 2014
Primäres Abschlussdatum December 2014
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) Baseline, 120 min post serelaxin infusion
Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) Baseline, 120 min post-infusion start
Sekundäres Ergebnis
Messen Zeitfenster
Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)) Baseline, 120 min post infusion
Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)) Baseline, 120 min post-infusion
Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only)) Baseline, 120 min post-infusion
Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)) Baseline, 120 min post-infusion
Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) Baseline, 120 min post-infusion
Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B) Baseline, 120 min post infusion
Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin 4 weeks
Einschreibung 47
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Terlipressin acetate

Beschreibung: IV bolus injection

Armgruppenetikett: Part A: Terlipressin acetate

Interventionsart: Drug

Interventionsname: Serelaxin (RLX030)

Beschreibung: 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

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Ort
Einrichtung: Novartis Investigative Site
Standort Länder

United Kingdom

Überprüfungsdatum

March 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: Part A: Terlipressin acetate

Art: Experimental

Beschreibung: Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.

Etikette: Part A: Serelaxin (RLX030)

Art: Experimental

Beschreibung: 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

Etikette: Part B Serelaxin (RLX030)

Art: Experimental

Beschreibung: 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.

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov