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NCT02911844: ERA-PAH

Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

Completed Phase 2 Results posted Last updated 9 December 2019
What this trial tests

Phase 2 trial testing Fulvestrant in Pulmonary Arterial Hypertension in 5 participants. Completed in 5 December 2018.

Timeline
10 April 2017
Primary endpoint
5 December 2018
5 December 2018

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date10 April 2017
Primary completion5 December 2018
Estimated completion5 December 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, female only, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline of Plasma Estradiol Levels Primary · Baseline to 9 weeks

Plasma estradiol levels are obtained and measured from blood samples collected from each participant. Difference in change from baseline to 9 weeks in plasma estradiol levels

GroupValue95% CI
Fulvestrant-1.26-1.7 – -0.26
Change From Baseline of Tricuspid Annular Plane Systolic Excursion (TAPSE) Primary · Baseline to 9 weeks

Measure obtained from echocardiogram completed on participants Difference in change from baseline to 9 weeks in TAPSE

GroupValue95% CI
Fulvestrant2-3 – 5.5
Change From Baseline of Six Minute Walk Distance Primary · Baseline to 9 weeks

Measure obtained from six minute walk test completed by participants Difference in change from baseline to 9 weeks in the six minute walk test distance

GroupValue95% CI
Fulvestrant3110 – 32
Change From Baseline of Plasma NT-proBNP Level Primary · Baseline to 9 weeks

Plasma NT-proBNP levels are obtained and measured from blood samples collected from each participant. Difference in change from baseline to 9 weeks in plasma NT-proBNP levels

GroupValue95% CI
Fulvestrant42.16.7 – 114

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fulvestrant
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (8 terms — click to expand)

ReactionSystemFulvestrant
DiarrheaGastrointestinal disorders
Injection Site PainGeneral disorders
Hot flashesNervous system disorders
Shoulder painGeneral disorders
Worsened dyspneaRespiratory, thoracic and mediastinal disorders
Joint painGeneral disorders
Worsening hemodynamicsCardiac disorders
Increased NT-proBNP levelCardiac disorders

Data from ClinicalTrials.gov NCT02911844 adverse events section.

Sponsor's own description

The main purpose of this clinical trial is to examine the feasibility and effects of fulvestrant in post-menopausal women with pulmonary arterial hypertension (PAH). The study will evaluate how well the drug is tolerated. The study will evaluate changes in circulating hematopoietic progenitor cells, plasma hormone levels, NT-proBNP, and other plasma biomarkers after the administration of fulvestrant. Changes in tricuspid annular plane systolic excursion, stroke volume index, right ventricular fractional area change, and other echo parameters after fulvestrant administration will be evaluated as well as changes in distance walked in six minutes.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical trial design and new therapies for pulmonary arterial hypertension.
    Sitbon O, Gomberg-Maitland M, Granton J, Lewis MI, et al · · 2019 · cited 144× · PMID 30545975 · DOI 10.1183/13993003.01908-2018
  2. Obesity, estrogens and adipose tissue dysfunction - implications for pulmonary arterial hypertension.
    Mair KM, Gaw R, MacLean MR. · · 2020 · cited 78× · PMID 32999709 · DOI 10.1177/2045894020952023
  3. New and Emerging Therapies for Pulmonary Arterial Hypertension.
    Spiekerkoetter E, Kawut SM, de Jesus Perez VA. · · 2019 · cited 72× · PMID 30216732 · DOI 10.1146/annurev-med-041717-085955
  4. Treatment Targets for Right Ventricular Dysfunction in Pulmonary Arterial Hypertension.
    Prisco SZ, Thenappan T, Prins KW. · · 2020 · cited 71× · PMID 33426379 · DOI 10.1016/j.jacbts.2020.07.011
  5. Sex Differences in Pulmonary Hypertension.
    Rodriguez-Arias JJ, García-Álvarez A. · · 2021 · cited 40× · PMID 35822006 · DOI 10.3389/fragi.2021.727558
  6. Sex Differences in Right Ventricular Dysfunction: Insights From the Bench to Bedside.
    Keen J, Prisco SZ, Prins KW. · · 2020 · cited 28× · PMID 33536939 · DOI 10.3389/fphys.2020.623129
  7. Fulvestrant for the Treatment of Pulmonary Arterial Hypertension.
    Kawut SM, Pinder D, Al-Naamani N, McCormick A, et al · · 2019 · cited 25× · PMID 31314997 · DOI 10.1513/annalsats.201904-328rl
  8. Sex-biased TGFβ signalling in pulmonary arterial hypertension.
    Wits M, Becher C, de Man F, Sanchez-Duffhues G, et al · · 2023 · cited 21× · PMID 37595264 · DOI 10.1093/cvr/cvad129

Verify or expand the search:

Other trials of Fulvestrant

Trials testing the same drug.

Other recruiting trials for Pulmonary Arterial Hypertension

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02911844.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing