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Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial (Portopulm)
This is an Open Label, Multicenter, pilot clinical trial to assess the efficacy and safety of an oral selective Endothelin Receptor Antagonist (ambrisentan) in patients with portopulmonary hypertension.
Preliminary evidence suggests that ambrisentan is safe and effective in patients with portopulmonary hypertension. The goal of therapy for these patients is to improve symptoms of dyspnea and to improve pulmonary hemodynamics to a mean pulmonary artery pressure <35 mm Hg in order to make patients eligible for liver transplantation. Therefore, the primary endpoints for this study will include 6 minute walk distance (6MWD) and pulmonary vascular resistance (PVR).
Eligible subjects will receive 5 mg ambrisentan once-daily for the first 4 weeks. After the initial 4-week period, investigators will increase study drug dose to 10 mg once daily (both 5 mg and 10 mg doses are FDA approved). If 10 mg is not tolerated in the opinion of investigator, then the investigator may decrease the dose back to 5 mg once daily. Primary outcome is a change in both the 6 Minute Walk Distance and in Pulmonary Vascular Resistance from baseline to Week 24. Subjects will be monitored with liver function tests (LFT) every 2 weeks for the first 8 weeks, then every 4 weeks thereafter. These safety laboratory tests may be performed at a local phlebotomy laboratory or at the Investigator clinic. In addition, the Investigator will assess each subject for safety and efficacy at Week 4, Week 12, and Week 24. Following Week 24, subjects will be assessed for safety and efficacy every 12 weeks. Patients will be followed for a total of 1 year. After 1 year, if the Investigator feels that continuing the treatment will be beneficial to the patients, they will be provided with ambrisentan by Gilead Pharmaceuticals, free of charge.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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California
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La Jolla, California, Verenigde Staten, 92093
- UCSD Medical Center
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic Florida
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts Medical Center
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- University of North Carolina
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Ohio
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Columbus, Ohio, Verenigde Staten, 43221
- The Ohio State University Medical Center
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Texas
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Dallas, Texas, Verenigde Staten, 75390
- UT Southwestern Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Subjects need to fulfill all of the following 4 criteria:
- Evidence of portal hypertension (by hemodynamic measurement, or by Doppler flow of portal circulation, or by clinical evidence of portal hypertension such as esophageal or gastric varices, as evidenced by prior upper endoscopy).
Evidence of pulmonary arterial hypertension by right heart catheterization (all three criteria need to be present) Right heart catheterization may have been performed up to 30 days prior to screening
- Mean PAP (pulmonary artery pressure) >25 mm Hg, and
- PVR (pulmonary vascular resistance) >240 dynes/s/cm5, and
- TPG (transpulmonary gradient = meanPAP -PAWP) >12 mm Hg
- Baseline AST, ALT < 5 times the upper limit of normal, total Bili < 3.0 mg/dl, and mild liver impairment with Child -Pugh class A or B
- Ages 18 years and above
Exclusion Criteria:
- Presence of any other etiology of pulmonary arterial hypertension (HIV, connective tissue disease, sickle cell, left heart failure, chronic thromboembolic PH, etc)
- Treatment with prostacyclins, other ERAs, or PDE5 inhibitors within 30 days of enrollment.
- Moribund state or anticipated death within 1 month.
- AST or ALT ≥ 5 times upper limit of normal
- Total bilirubin ≥ 3.0 mg/dl
- Significant lung disease (obstructive lung disease with FEV1 < 1L, or FEV1/FVC <50%; or restrictive lung disease with Total Lung Capacity < 60% predicted). PFTs may have been performed up to 6 months prior to enrollment.
- Pregnancy
- Age <18 years
- Child -Pugh class C
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Ambrisentan (24 Weeks), Extension (4 Weeks)
Open Label Ambrisentan
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Ambrisentan once-daily in the morning with or without food.
The adult dose selected for this study will be 5 mg for the first 4 weeks.
After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety.
Subjects will remain on 10mg until they complete the study.
Dose adjustments may be made based on side effects.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in Pulmonary Vascular Resistance
Tijdsspanne: from baseline to Week 24
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Change in Pulmonary Vascular Resistance from baseline to Week 24 for all patients (using cardiac output [CO] measured by the thermodilution method and reported as percent difference from baseline).
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from baseline to Week 24
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6 Minute Walk Distance
Tijdsspanne: Change from baseline to Week 24
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Change from baseline in 6 Minute Walk Distance to Week 24 for all patients.
(difference measured in meters).
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Change from baseline to Week 24
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ioana Preston, MD, Tufts Medical Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Ambrisentan Portopulm Study
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Ambrisentan
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GlaxoSmithKlineBeëindigdHypertensie, pulmonaalFrankrijk, Verenigde Staten, Duitsland, Spanje, Italië, Japan, Hongarije, Russische Federatie, Argentinië
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Medical University of GrazIngetrokkenPortopulmonale hypertensieOostenrijk
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Soumya ChatterjeeGilead SciencesVoltooid
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Gilead SciencesVoltooidStudy to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.Pulmonale arteriële hypertensie
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University of Alabama at BirminghamVoltooidPulmonale arteriële hypertensieVerenigde Staten
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Gilead SciencesVoltooid
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GlaxoSmithKlineVoltooid
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Gilead SciencesVoltooid
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Bnai Zion Medical CenterRambam Health Care CampusOnbekend
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GlaxoSmithKlineBeëindigdHypertensieSpanje, Duitsland, Korea, republiek van, Canada, Japan, Nederland, Verenigd Koninkrijk, Verenigde Staten, China, Oostenrijk, Israël, Argentinië, Russische Federatie, Mexico, Saoedi-Arabië, Tsjechische Republiek