| CTRI Number |
CTRI/2019/04/018679 [Registered on: 22/04/2019] Trial Registered Prospectively |
| Last Modified On: |
04/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Other |
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Public Title of Study
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A clinical trial to study the effects of Ifetroban in patients with with diffuse cutaneous systemic sclerosis or systemic sclerosis-associated pulmonary arterial hypertension. |
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Scientific Title of Study
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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 or systemic sclerosis-associated pulmonary arterial hypertension. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CPI-IFE-004 Version 04.1 India Dated 20-Aug-2018 |
Protocol Number |
| NCT02682511 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Sonika Newar |
| Designation |
General Manager- Medical Monitoring and Safety – Monitoring |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Faridabad
HARYANA
121003
India |
| Phone |
918800799887 |
| Fax |
91-129-6613520 |
| Email |
sonika.newar@jssresearch.com |
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Details of Contact Person
Public Query
Modification(s)
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| Name |
Dr Jayashri Krishnan |
| Designation |
Director – Operations |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Faridabad
HARYANA
121003
India |
| Phone |
919771407484 |
| Fax |
91-129-6613520 |
| Email |
jayashri.krishnan@jssresearch.com |
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Source of Monetary or Material Support
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| Cumberland Pharma Inc. 2525 West End Avenue, Suite 950, Nashville, TN 37203, USA |
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Primary Sponsor
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| Name |
Cumberland Pharma Inc |
| Address |
2525 West End Avenue, Suite 950,
Nashville,
TN 37203, USA
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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India
United States of America |
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Sites of Study
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| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chavan Ravindranath Brahmadeo |
B. J. Govt. Medical College and Sassoon General Hospital |
Ground Floor, HOD Chamber, Department of Skin & VD, Agarkar Nagar, Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra 411001
Pune
MAHARASHTRA |
9423146016
drchavan1@gmail.com |
| Dr Sunil Kumar singh |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Room No 84, 1st Floor, General OPD, Department of Rheumatology, Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri(West) Mumbai-400053
Mumbai
MAHARASHTRA |
9321452959
sunilkumar.r.singh@relianceada.com |
| Dr Shefali Khanna |
Post Graduate Institute of Medical Education & Research |
Room No 14, 4th Floor, Department of Internal Medicine, Nehru Hospital, Sec 12, Chandigarh 160012
Chandigarh
CHANDIGARH |
9417372439
sharmashefali@hotmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Post Graduate Institute of Medical Education & Research, |
Approved |
| Institutional Ethics Committee of B. J. Govt. Medical College and Sassoon General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M349||Systemic sclerosis, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Ifetroban |
The interventional product/placebo will be administered at a dose: 250mg once daily through oral route for 365 days |
| Comparator Agent |
Placebo |
Placebo will be administered at a dose of 250mg once daily through oral route for 365 days |
|
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
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| ExclusionCriteria |
| Details |
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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Double Blind Double Dummy |
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Primary Outcome
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| Outcome |
TimePoints |
1.Incidence and severity of treatment emergent adverse events (TEAEs)
2.Incidence of clinically significant shifts in laboratory values
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
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1.15 months
2.12 months
3.26 & 52 weeks from baseline
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Secondary Outcome
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Target Sample Size
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Total Sample Size="34"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
27/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/03/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
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Not Yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The study is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients with Diffuse Cutaneous Systemic Sclerosis or Systemic Sclerosis-Associated Pulmonary Arterial Hypertension. Following are the trial objective and purposes: i) To determine the safety of ifetroban in patients with dcSSc or SSc-PAH compared to placebo as measured by treatment emergent adverse events (TEAEs) and standard laboratory assessments. ii) To determine if ifetroban can modify the progression of myocardial fibrosis in patients with diffuse SSc or SSc-PAH compared to placebo as determined by cardiac magnetic resonance imaging (MRI). iii) To determine if ifetroban improves right ventricular function in patients with dcSSc or SSc-PAH compared to placebo as determined by echocardiography. iv) To determine if ifetroban improves exercise capacity in patients with dcSSc or SSc-PAH compared to placebo as determined by the six minute walk test (6MWT). v) To determine if ifetroban reduces skin and peripheral vascular disease in patients with dcSSc or SSc-PAH compared to placebo as measured by active digital-tip ulcer count, patient reported outcome (visual analog scale or VAS) and the modified Rodnan skin thickness score. vi) To determine if ifetroban improves quality of life in patients with dcSSc or SSc-PAH compared to placebo as measured by the patient completed mSHAQ, RAND-36, UCLA SCTC GIT 2.0, and the WHODAS 2.0 Questionnaires. vii) To determine if ifetroban improves pulmonary function in patients with dcSSc or SSc-PAH compared to placebo as measured by spirometry and diffusion capacity for carbon monoxide (DLCO). viii) To determine if ifetroban improves laboratory and physical evidence of inflammation in patients with dcSSc or SSc-PAH compared to placebo as measured by serum biomarkers (an array panel focusing on fibrosis), erythrocyte sedimentation rate and physical examination. ix) To determine if ifetroban alters biomarkers in the skin in patients with dcSSc compared to placebo as measured by skin biopsy biomarkers (an array panel focusing on fibrosis). |