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CTRI Number  CTRI/2014/09/005075 [Registered on: 30/09/2014] Trial Registered Prospectively
Last Modified On: 24/09/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to Determine the Safety of Ifetroban Injection in patients with Hepatorenal Syndrome (a condition of renal failure in patients with liver disease) 
Scientific Title of Study   A Multi Center, Double-Blind, Randomized, Controlled Study to Determine the Safety and Pharmacokinetics of Ifetroban Injection in Hepatorenal Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CPI-IFE-001(Amendment 2) dated 24 Aug 2011.  Protocol Number 
NCT01436500  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Subhranshu Nayak 
Designation  Medical Monitor 
Affiliation  Max Neeman International 
Address  Max Neeman International, Max House, 1st Floor 1, Dr. Jha Marg, Okhla Phase-III,

South
DELHI
110020
India 
Phone  91-9643430098  
Fax  91-11-41001945  
Email  Subhranshu.Nayak@maxneeman.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Shariq Anwar 
Designation  Head Operations 
Affiliation  Max Neeman International 
Address  Max Neeman International, Max House, 1st Floor 1, Dr. Jha Marg, Okhla Phase-III

South
DELHI
110020
India 
Phone  91-9810979215  
Fax  91-11-40548168  
Email  Shariq.Anwar@maxneeman.com  
 
Source of Monetary or Material Support  
Cumberland Pharmaceuticals Inc. 
 
Primary Sponsor  
Name  Cumberland Pharmaceuticals Inc 
Address  2525 West End Avenue, Suite 950 Nashville, Tennessee 37203 Contact No. 615-255-0068 Fax No. 615-255-0094  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Max Neeman International  Max House, 1 Dr. Jha Marg, Okhla, Phase-III, New Delhi-110020 Phone: 91-11-40772100  
 
Countries of Recruitment     India
United States of America  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Joye Varghese Selvaraj  Global Hospital and Health city  Global Hospital and Health city Department of Hepatology 439, Cheran Nagar, Perumbakkam
Chennai
TAMIL NADU 		 91-8754005669
91-4444777097
joyvargese@gmail.com 
Dr Rakhi Maiwall  Institute of Liver and Biliary Sciences  Institute of Liver and Biliary Sciences Department of Hepatology D-1, Vasant Kunj, 110070
South West
DELHI 		 91-9873173140

rakhi_2011@yahoo.co.in 
Dr Vaibhav Ganjewar  Midas Multispeciality Hospital Pvt. Ltd.  MIDAs Heights, 07, Central Bazaar Road, Ramdaspeth, 440010
Nagpur
MAHARASHTRA 		 91-7720035616

vaibhav@ganjewar.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee Global Hospital and Health city  Approved 
Institutional Ethics Committee Institute of Liver and Biliary Sciences  Approved 
Institutional Ethics Committee, Midas Multispeciality Hospital Pvt. Ltd.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 1 and Type 2 Hepatorenal Syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ifetroban  5mg to 150mg administered once daily as a 60 minute IV infusion during the 72-hour Treatment Period. A total of three doses will be administered. Patients will not receive additional doses after 72 hours. 
Comparator Agent  Placebo  5% Dextrose in water (D5W) will be used as the placebo during the 72-hour Treatment Period. A total of three doses of placebo will be administered. Patients will not receive additional doses of placebo after 72 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Note- There is no upper limit specified in the protocol.

Inclusion Criteria
1. Chronic liver disease, defined as cirrhosis with ascites based on clinical findings (biopsy not necessary).

2. Subjects with either Type 1 or Type 2 renal dysfunction defined as follows:
a) Type 1:
i) At least a doubling of the initial serum creatinine to >220 μmol/L
(2.5 mg/dL), occurring over a period of less than 2 weeks.
OR
ii) A 50% or greater reduction in the initial 24-hour creatinine
clearance to <20 mL/min occurring over a period of less than
2 weeks.
b) Type 2: defined as at least a 33% reduction in creatinine clearance
occurring over a period of greater than 2 weeks, with a serum creatinine
>133μmol/L (1.5 mg/dL).

3. Oliguria occurring within 48 hours prior to 1st administration CTM. Oliguria is defined as either of the following:
a. An average urine output of <35 mL/hr measured for at least 4 hours, occurring with a measured central venous pressure (CVP) >12 mmHg.
OR
b. In the absence of CVP monitoring, oliguria that is not corrected by a fluid challenge of at least 20mL/kg isotonic crystalloid or comparable volume of colloid.

 
 
ExclusionCriteria 
Details  1. History of allergy or hypersensitivity to ifetroban
2. Pregnant or nursing
3. Less than 18 years of age
4. SCr > 5.0 mg/dL
5. Platelet count at screening of <30 x 103 per μL
6. Active gastrointestinal hemorrhage
7. Evidence of obstructive or parenchymal renal disease (e.g., acute tubular necrosis, glomerular diseases, interstitial nephritis, and urinary obstruction, or lab results indicating proteinuria >500 mg/day, microhematuria [>50 RBCs/high power field], and/or abnormal renal ultrasound scanning).
8. Current or recent (within the preceding 5 days) treatment with any of the
following drugs: aminoglycosides, acyclovir, cisplatin, methotrexate,
cyclosporine, amphotericin B.
9. Presence of shock defined as hypotension, with a mean arterial pressure less than 50 mmHG.
10. NYHA class 3 or 4 heart failure.
11. Presence of hepatocellular carcinoma not transplantable by Milan criteria
12. Cardiopulmonary arrest without full recovery of mental status
13. Moribund and death expected within five days
14. Uncontrolled bacterial or fungal infections, defined as receiving appropriate antimicrobial therapy for >24 hours
15. Burns >30% body surface area
16. Exposed to investigational drugs within 30 days before 1st CTM administration.
17. Inability to understand the requirements of the study. (Subjects must be willing to provide written informed consent or consent of legally recognized representative, as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB], and agree to abide by the study restrictions if the subject is incapacitated, informed consent will be sought from a legally recognized representative).
18. Refusal to provide written authorization for use and disclosure of protected health information.
19. Be otherwise unsuitable for the study, in the opinion of the Investigator.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• To determine the pharmacokinetic profile of multiple daily intravenous doses of ifetroban and its major metabolite, ifetroban acylglucuronide.
• To determine the tolerability and safety of ifetroban injection in patients with HRS.
 		 During the 72-hour Treatment Period, at Hour 168 and at day 28.
Adverse events will be monitored throughout the Post-treatment Period. 
 
Secondary Outcome  
Outcome  TimePoints 
To determine if ifetroban changes renal function, showing evidence of HRS reversal.  During the 72-hour Treatment Period and at Hour 168 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 15/01/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/04/2012 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This Phase 2a double-blind, multi-center, randomized, controlled study will evaluate the pharmacokinetics, safety and tolerability of ifetroban administered as daily IV doses in recently diagnosed HRS patients. Patients will be stratified based upon Type 1 or Type 2 HRS diagnosis. Cohorts of eight HRS patients (per HRS type) will be assigned sequentially to escalating daily dose levels of ifetroban or vehicle (3:1) for assessment of pharmacokinetics. Escalation to the next dose level will be contingent upon the safety and tolerability of the preceding dose level as determined by a DSMB. If all regimens are studied, a total of 64 patients will be enrolled. 
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