| CTRI Number |
CTRI/2019/08/020846 [Registered on: 22/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety and efficacy of Saroglitazar 4 mg in the
treatment of Alcoholic Liver Disease. |
|
Scientific Title of Study
|
A Prospective, Multi-centre, Double-blind, Randomized Trial
of Saroglitazar 4 mg versus Placebo in Patients With
Alcoholic Liver Disease. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SARO.18.002 PROTOCOL Version 2.0 Phase II.26June2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath K |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
manjunath.k@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath K |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
manjunath.k@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath K |
| Designation |
Deputy General Manager |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717665555 |
| Fax |
|
| Email |
manjunath.k@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
|
Cadila Healthcare Ltd. Zydus Tower Satellite Cross Road, Ahmedabad 380015 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower Satellite Cross Road, Ahmedabad 380015 Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan Goyal |
Apex Hospital Pvt. Ltd |
"SP 4 & 6, Malviya Industrial Area
Near Apex Circle ,Malviya Nagar
Jaipur - 302017
Jaipur
RAJASTHAN |
8432432000
mohandr77@gmail.com |
| Dr Shrikant Vishnu Deshpande |
Ashirwad Hospital and Research Centre |
Maratha Section, Near Jijamata Udyan, Ulhasnagar, 421004 Maharashtra
Thane
MAHARASHTRA |
9822017445
writetoshrikant@rediffmail.com |
| Dr Soham Sunil Kumar Doshi |
Dr. Vasantrao Pawar Centre For Developmental Therapeutics Translational Research |
4th Floor near MRD section in medical college
Dr. Vasantrao Pawar Medical College Hospital & Research
Centre, Vasantdada Nagar, Adgaon Nashik
Nashik
MAHARASHTRA |
9021416946
dr.sohamdoshi@gmail.com |
| Dr Ayaskanta singh |
Institute of Medical Science and SUM Hospital |
Institute of Medical Science (IMS) and SUM Hospital ,
Department of Gastroenterology
K-8 Kalinga Nagar, Ghatikia Bhubaneswar, Odisha – 751003 India
Khordha
ORISSA |
9437155625
ayaskant1ce@gmail.com |
| Dr Asokananda Konar |
Peerless Hospitex Hospital And Research Center Limited |
Peerless Hospitex Hospital And Research Center Limited
360, Panchasayar, Kolkata- 700 094
Kolkata
WEST BENGAL |
9830878194
asoke.konar@gmail.com |
| Dr Siddhartha Ramakrishna Bala Krishnan |
SRM Institute of Medical Science (SIMS Hospital) |
SRM Institute of Medical Science (SIMS Hospital)
No. 1 Jawaharlal Nehru Salai (100 feet Road )
Vadapalani, Chennai, Tamilnadu - 600026
Chennai
TAMIL NADU |
9994614890
drramakrishna.bs@simshospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Asirwad Ethics Committee Ashirwad Hospital and Research Centre Maratha Section, Near Jijamata Udyan, Ulhasnagar - 421004 Maharashtra |
Approved |
| Clinical Research Ethics Committee Peerless Hospitex Hospital And Research Center Limited (Formerly : Peerless Hospital and Research centre) 360, Panchasayar, Kolkata- 700 094 |
Approved |
| IEC IMS and SUM Hospital IMS and SUM Hospital K8 kalinga nagar shampur bhubaneswar Khordha Orissa - 751003 India |
Approved |
| Institutioal Ethics Committee Apex Hospital Pvt.Ltd SP 4 & 6, Malviya Industrial Area Near Apex Circle ,Malviya Nagar Jaipur - 302017 Rajashthan |
Approved |
| Institutioal Ethics Committee Dr. Vasantrao Pawar Medical College Hospital & Research Centre Nashik - 422003 Maharashtra India |
Approved |
| Institutional Ethics Committe SRM Institute of Medical Science No. 1 Jawaharlal Nehru Salai (100 feet Road) Vadapalani, Chennai, Tamilnadu - 600026 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K709||Alcoholic liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Placebo tablet Oral OD
Duration 24 weeks |
| Intervention |
Saroglitazar |
4 mg tablet Oral OD
Duration 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Heavy alcohol consumption (defined as >20 grams per day on average in women and > 60
grams per day on average in men for a minimum of 6 months and within the 6 weeks prior
to study enrollment).
2)Should meet the following criteria in the FibroMax test:
2a) Fibro Test (for hepatic fibrosis): Grades F1, F2 and F3.
2b) Steato Test (for hepatic steatosis): Grades S1 and S2.
2c) Ash Test (for alcoholic steatohepatitis): Grades H1 and H2.
3)Ability to understand and give informed consent for participation |
|
| ExclusionCriteria |
| Details |
1)Patients with severe alcoholic liver disease as determined by the following criteria:
a) Maddrey discriminant function (DF) score more than 32.
b) Model for end stage liver disease (MELD) score ≥14
2)Will be excluded if the patient meets the following criteria in the FibroMax test.
2a) Fibro Test (for hepatic fibrosis):Grades F0 and F4.
2b) Steato Test (for hepatic steatosis): Grades S0 and S3.
2c) Ash Test (for alcoholic steatohepatitis): Grades H0 and H3.
3)Severe renal impairment (Estimated glomerular filtration rate below 60 ml/min per 1.73m2).
4)Uncontrolled upper gastrointestinal tract bleeding.
5)AST and ALT values more than 400 IU/L.
6)Participants on hepatotoxic medications like antitubercular medication, antiviral medication,
etc.
7)Pregnant, attempting to conceive, or lactating women.
8)Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days prior to screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Change in the following grades of FibroMax Test at 12 and 24 weeks [Timeframe:
baseline, 12 and 24 weeks].
a) Fibro Test (for hepatic fibrosis).
b) Steato Test (for hepatic steatosis).
c) Ash Test (for alcoholic steatohepatitis).
2. Change in MELD score at 6, 12 and 24 weeks.
3. Change in Maddrey Discriminant function (DF) at 6, 12 and 24 weeks.
4. Change in GGT levels at 6, 12 and 24 weeks.
5. Change in AST levels at 6, 12 and 24 weeks.
6. Change in ALT levels at 6, 12 and 24 weeks. |
1)Timeframe:baseline, 12 and 24 weeks
2. at 6, 12 and 24 weeks.
3. at 6, 12 and 24 weeks.
4. at 6, 12 and 24 weeks.
5. at 6, 12 and 24 weeks.
6. at 6, 12 and 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency and severity of AEs and serious AEs.
2. Alteration in laboratory parameters.
3. Twelve-lead electrocardiogram.
4. Vital signs.
5. Physical examination. |
All visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/09/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Alcoholic liver disease (ALD) comprises a clinical-histologic spectrum including fatty liver, alcoholic hepatitis (AH), and cirrhosis with its complications. This condition develops in persons with a history of prolonged and heavy alcohol use. A number of therapies have been assessed for the treatment of ALD, but only two drugs (Prednisolone and Pentoxifylline) have been incorporated into the treatment guidelines published by the American Association for the Study of Liver Disease and the European Association for the Study of the Liver. Thus, there is a need to develop a treatment which will provide effective therapy to patients. |