A clinical trial to study the effects of Ifetroban in patients with with diffuse cutaneous systemic sclerosis or systemic sclerosis-associated pulmonary arterial hypertension.
- Conditions
- Health Condition 1: M349- Systemic sclerosis, unspecified
- Registration Number
- CTRI/2019/04/018679
- Lead Sponsor
- Cumberland Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Diffuse Cutaneous SSc Inclusion Criterion
1.Adults fulfilling the 2013 ACR/EULAR classification criteria for SSc with diffuse cutaneous SSc within 7 years following initial diagnosis as defined by onset of the first non-Raynaud symptom .
SSc-PAH Inclusion Criteria
1.Adults fulfilling the 2013 ACR/EULAR classification criteria for SSc with confirmed SSc-PAH (confirmed via previous cardiac catheterization)
2.Stable oral therapy for PAH for at least 30 days (monotherapy or any combination)
3.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 rituximab or pirfenidone;
6.Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
7.Significant lung disease, defined as FVC < 50% predicted or DLCO <40% predicted;
8.Significant kidney disease, defined as Glomerular Filtration Rate [GFR] < 60 ml/min;
9.Have moderate or severe hepatic impairment;
10.Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
11.Known hypersensitivity to gadolinium;
12.Any cause of pulmonary hypertension other than WHO Group I associated with SSc;
13.Use of aspirin > 81 mg per day in the last two weeks;
14.Use of warfarin, heparin or other anticoagulants in the last 30 days;
15.Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
16.Have a history of allergy or hypersensitivity to ifetroban;
17.Have taken investigational drugs within 30 days before Investigational Medicinal Product (IMP) administration;
18.Inability to understand the requirements of the study and abide by the study restrictions and to return for the required treatments and assessments;
19.Be otherwise unsuitable for the study, in the opinion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Incidence and severity of treatment emergent adverse events (TEAEs) <br/ ><br>2.Incidence of clinically significant shifts in laboratory values <br/ ><br>3.Change from baseline in extracellular volume (ECV), native T1 time, right ventricular ejection fraction (RVEF), left ventricular ejection fraction (LVEF) and pulmonary flow dynamics on MRI <br/ ><br>Timepoint: 1.15 months <br/ ><br>2.12 months <br/ ><br>3.26 & 52 weeks from baseline <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method ATimepoint: NA