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Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial

Information source: Tufts Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Portopulmonary Hypertension

Intervention: Ambrisentan (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Tufts Medical Center

Official(s) and/or principal investigator(s):
Ioana Preston, MD, Principal Investigator, Affiliation: Tufts Medical Center

Overall contact:
Karen Visnaw, RN, BS, ADN, Phone: 617-636-1334, Email: Kvisnaw@Tuftsmedicalcenter.org

Summary

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 6MWD and in PVR 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.

Clinical Details

Official title: Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in PVR

Secondary outcome: 6 Minute Walk Distance

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Subjects need to fulfill all of the following 4 criteria: 1. 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). 2. 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

3. 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

4. Ages 18 years and above Exclusion Criteria: 1. Presence of any other etiology of pulmonary arterial hypertension (HIV, connective tissue disease, sickle cell, left heart failure, chronic thromboembolic PH, etc) 2. Treatment with prostacyclins, other ERAs, or PDE5 inhibitors within 30 days of enrollment. 3. Moribund state or anticipated death within 1 month. 4. AST or ALT ≥ 5 times upper limit of normal 5. Total bilirubin ≥ 3. 0 mg/dl 6. 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. 7. Pregnancy 8. Age <18 years

9. Child - Pugh class C

Locations and Contacts

Karen Visnaw, RN, BS, ADN, Phone: 617-636-1334, Email: Kvisnaw@Tuftsmedicalcenter.org

UCSD Medical Center, La Jolla, California 92093, United States; Recruiting
Ileana Rubio, Phone: 858-657-7122, Email: irubio@ucsd.edu
David S. Poch, MD, Principal Investigator

Mayo Clinic Florida, Jacksonville, Florida 32224, United States; Recruiting
Pam Long, RN, Phone: 904-953-2255, Email: Long.pamela@mayo.edu
Charles D Burger, M.D, Principal Investigator

Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Karen Visnaw, RN, BS, ADN, Phone: 617-636-1334, Email: Kvisnaw@Tuftsmedicalcenter.org
Ioana Preston, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Samantha Earnhardt, MPH, Phone: 919-966-2531, Email: samearn@med.unc.edu
James Ford, MD, Principal Investigator

The Ohio State University Medical Center, Columbus, Ohio 43221, United States; Recruiting
Janice Drake, CRT, CCRP, Phone: 614-366-2287, Email: Janice.Drake@osumc.edu
Namita Sood, MD, Principal Investigator

UT Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Namrata Banga, Phone: 214-645-7148, Email: Namrata.Banga@UTSouthwestern.edu
Megan Devine, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Gwendolyn Goodloe, Phone: 713-798-2556, Email: Gmb@bcm.edu
Zeenat Safdar, MD, Principal Investigator

Additional Information

Starting date: March 2010
Last updated: December 4, 2014

Page last updated: August 23, 2015

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