ACTIVE_NOT_RECRUITING

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Conditions

Scleroderma, Diffuse Scleroderma, Systemic Scleroderma, Limited Sclerosis, Progressive Systemic Skin Diseases Connective Tissue Diseases Pathologic Processes Autoimmune Diseases Ifetroban Scleroderma Systemic Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

Official Title

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH)

Quick Facts

Study Start:2017-01

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02682511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom. 1. Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization 2. Stable oral therapy for PAH for at least 30 days (monotherapy or combination) 3. New York Heart Association (NYHA) Class I-III Heart Failure	1. Have a diagnosis of systemic sclerosis sine scleroderma; 2. Be less than 18 years of age or greater than or equal to 80 years of age; 3. Be pregnant, nursing, or planning to become pregnant; 4. Current or planned treatment with prostanoid therapy; 5. Current or planned treatment with pirfenidone; 6. Use of rituximab in the last 3 months; 7. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months; 8. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent; 9. Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted; 10. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min; 11. Have moderate or severe hepatic impairment; 12. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia); 13. Known hypersensitivity to gadolinium; 14. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc; 15. Use of aspirin \> 81 mg per day in the last two weeks; 16. Use of warfarin, heparin or other anticoagulants in the last 30 days; 17. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias; 18. Have a history of allergy or hypersensitivity to ifetroban; 19. Have taken investigational drugs within 30 days before study treatment administration; 20. Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments; 21. Be otherwise unsuitable for the study, in the opinion of the investigator.

Inclusion Criteria

Exclusion Criteria

1. Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria and dcSSc within 7 years following initial diagnosis as defined by the onset of the first non-Raynaud symptom.
1. Adults fulfilling the 2013 American College of Rheumatology/ European Union League Against Rheumatism Classification Criteria with confirmed SSc-PAH (limited or dcSSc) confirmed via previous cardiac catheterization
2. Stable oral therapy for PAH for at least 30 days (monotherapy or combination)
3. New York Heart Association (NYHA) Class I-III Heart Failure

1. Have a diagnosis of systemic sclerosis sine scleroderma;
2. Be less than 18 years of age or greater than or equal to 80 years of age;
3. Be pregnant, nursing, or planning to become pregnant;
4. Current or planned treatment with prostanoid therapy;
5. Current or planned treatment with pirfenidone;
6. Use of rituximab in the last 3 months;
7. Use of mycophenolic acid (Myfortic, CellCept) at a stable dose for less than 3 months;
8. Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
9. Significant lung disease, defined as FVC \< 50% predicted or DLCO \<40% predicted;
10. Significant kidney disease, defined as Glomerular Filtration Rate (GFR) \< 60 ml/min;
11. Have moderate or severe hepatic impairment;
12. Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
13. Known hypersensitivity to gadolinium;
14. Any cause of pulmonary hypertension other than World Health Organization (WHO) Group I associated with SSc;
15. Use of aspirin \> 81 mg per day in the last two weeks;
16. Use of warfarin, heparin or other anticoagulants in the last 30 days;
17. Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
18. Have a history of allergy or hypersensitivity to ifetroban;
19. Have taken investigational drugs within 30 days before study treatment administration;
20. Inability to understand the requirements of the study, inability to understand spoken English and abide by the study restrictions and to return for the required treatments and assessments;
21. Be otherwise unsuitable for the study, in the opinion of the investigator.

Contacts and Locations

Principal Investigator

Evan Brittain, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

The Universtity of Arizona Arthrtis Center

Tucson, Arizona, 85724

United States

UCLA

Los Angeles, California, 90095-1670

United States

Cleveland Clinic - Florida

Weston, Florida, 33331

United States

Johns Hopkins University

Baltimore, Maryland, 21224

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Hospital for Special Surgery

New York, New York, 10021

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Medical University of South Carolina

Charleston, South Carolina, 29403

United States

Baylor Research Institute

Dallas, Texas, 75204-651

United States

Collaborators and Investigators

Sponsor: Cumberland Pharmaceuticals

Evan Brittain, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01

Study Completion Date2026-05

Study Record Updates

Study Start Date2017-01

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Ifetroban
Scleroderma
Systemic Sclerosis

Additional Relevant MeSH Terms

Scleroderma, Diffuse
Scleroderma, Systemic
Scleroderma, Limited
Sclerosis, Progressive Systemic
Skin Diseases
Connective Tissue Diseases
Pathologic Processes
Autoimmune Diseases