| CTRI Number |
CTRI/2022/06/043453 [Registered on: 23/06/2022] Trial Registered Prospectively |
| Last Modified On: |
13/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Evaluate the Safety and Efficacy of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in hepatitis |
|
Scientific Title of Study
|
Evaluation of Safety and Efficacy of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in hepatitis: A Phase IV, Prospective, Open Label, Multi-centric, Single Arm, Clinical Study. |
| Trial Acronym |
Hepamerz |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT- CE-HM- 2022/Version 3.0/Dated- 04-Apr-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trail Operations |
| Affiliation |
CliniExperts Research Services Private Limited |
| Address |
Unit No. 325, City Center Mall, Plot no. 5, Sector 12, Dwarka
New Delhi
DELHI
110075
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
devesh.kumar@cliniexperts.com |
|
|
Source of Monetary or Material Support
|
| Win Medicare Pvt. Ltd.
1311, MODI TOWER, 98 NEHRU PLACE NEW DELHI, 110019 IN
|
|
|
Primary Sponsor
|
| Name |
Win Medicare Pvt Ltd |
| Address |
1311, Modi Tower, 98 Nehru Place New Delhi, 110019 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debananda Sahoo |
All India Institute of Medical Sciences, BBSR AIIMS |
All India Institute of Medical Sciences, BBSR AIIMS Bhubaneswar Sijua P/O Patrapada Bhubaneswar Khordha
Khordha
ORISSA |
8763290804
drdebanandasahoo@gmail.com |
| Dr Ambanna Gowda |
Citizen Hospital |
#14, 2nd Main Dispensary Road, Kalasipalya, Bangalore - 560002
Bangalore
KARNATAKA |
9845270377
dr.ambanagowda@gmail.com |
| Dr CS Gillurkar |
Gillurkar Multispeciality Hospital and Research Centre |
20, Reshimbag, Umred Road, nagpur - 440009
Nagpur
MAHARASHTRA |
9890005678
cgillurkar@yahoo.com |
| Dr Sanjiv Maheshwari |
Jawahar Lal Nehru Medical College & Attached Hospitals |
Kala Bagh, Ajmer-305001,Rajasthan
Ajmer
RAJASTHAN |
9460479888
doctor.sanjiv@gmail.com |
| Dr Sandeep Kumar Gupta |
M.V. Hospital and Research Centre |
314/30, Mirza Mandi, Chowk, Lucknow -226003
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Suman Bandi |
Mahatma Gandhi Memorial Hospital |
Sherpura, Warangal, Telangana - 506002
Warangal
TELANGANA |
9948293597
drsuman.krcwgl@gmail.com |
| Dr Harsh Mittal |
Panchsheel Hospital Pvt. Ltd. |
c-3/63-A,64-A, Yamuna Vihar, Delhi - 110053
North
DELHI |
9560506410
harshmittal86@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Gillurkar Hospital Ethics Committee |
Approved |
| Institutional Committee of MV Hospital and Research Centre |
Approved |
| Institutional Committee of Panchsheel Hospital |
Approved |
| Institutional Ethics Committee Citizen Hospital |
Approved |
| Institutional Ethics Committee JLN Medical College |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, AlIMS Bhubaneswar |
Approved |
| Kakatiya Institutional Ethics Committee Kakatiya Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets |
Mode and frequency of administration - 2 tablets three times daily after meals. Tablets should be swallowed whole with water and not to be chewed, crushed, broken.
Duration of treatment: 14 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male/Female patients aged between 18-70 years with a clinical diagnosis of Hepatitis. The definition of Hepatitis is as mentioned below:
Hepatitis is a term to describe inflammation (Swelling) in the liver. It can be caused due to viral infection or when liver is exposed to harmful substances such as alcohol. Hepatitis may occur with limited or no symptoms, but often leads to jaundice, anorexia (poor appetite) and malaise. Hepatitis is of two types: Acute and Chronic.
2. Willingness to comply with the study schedule and procedures.
3. Patient willing to give written informed consent prior to screening.
|
|
| ExclusionCriteria |
| Details |
1. Subject not willing to give written informed consent
2. Severe renal insufficiency (A serum creatinine value over 1.5 mg/100 ml)
3. Known hypersensitivity to any ingredient of the study drug.
4. Acute or chronic liver failure
5. Severe sepsis
6. Advanced cardiac or pulmonary disease
7. Neurologic disease (including head injury and drug intoxication).
8. Pregnancy and Lactation.
9. Female Subject not ready to use contraceptive measures during the trial period
10. Subject with any condition which in opinion of the investigator makes the him/her unsuitable for inclusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence, intensity, and causal relationship to labelled and un-labelled adverse reaction during the study period (Post screening after drug administration)
2. Incidence, intensity, and causal relationship to Serious Adverse Events (SAEs) during the entire study period (Post screening after drug administration) |
Day 0 to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in laboratory parameters SGOT, SGPT, Alkaline Phosphatase, Serum Ammonia, Serum Bilirubin at the day 0, day 7 and day 14 of the treatment.
Physicians assessment in improvement according to a modified version of the Clinical Global Impression-Improvement (CGI-I) scale.
|
Day-0, Day-07 & Day-14 |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/06/2022 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Phase IV, Prospective, Open Label, Multi-centric, Single Arm, Clinical Study.
To evaluate the Efficacy & safety of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in Hepatitis.
200+20 subjects will be enrolled in the study to evaluate 200 enrolled subjects who completes the study The fixed dose combination of L-Ornithine-L-Aspartate 150mg, Pancreatin IP 100mg enteric coated tablets possess hepatoprotector-detoxicant, hypoazotemic action which is based on direct influence upon the basic mechanism of ammonia neutralization in hepatocytes (formation of urea from ammonia, increase in glutamine synthesis).
In furtherance to continuous assessment of benefit risk profile of the FDC L-Ornithine-L-Aspartate 150mg, Pancreatin IP 100mg enteric coated tablets, the present phase IV study has been planned to assess the safety and efficacy profile in Asian Indian population suffering with hepatitis. |