|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2014/07/004738 |
|
Date of registration:
|
15-07-2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A clinical trial to study Hepatitis E virus infection in liver transplant recipients in India
|
|
Scientific title:
|
Hepatitis E virus infection in liver transplant recipients in India |
|
Date of first enrolment:
|
17-04-2014 |
|
Target sample size:
|
150 |
|
Recruitment status: |
Open to Recruitment |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9101 |
|
Study type:
|
Observational |
|
Study design:
|
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr Sanjiv Saigal
|
|
Address:
|
Medanta The Medicity,
Sector 38,
122001
Gurgaon, HARYANA
India |
|
Telephone:
|
9811552928 |
|
Email:
|
sanjivsaigal@hotmail.com |
|
Affiliation:
|
Institute of liver transplantation and regenerative medicine, |
|
|
Name:
|
Yogesh Saini
|
|
Address:
|
Medanta The Medicity,
Sector 38,
122001
Gurgaon, HARYANA
India |
|
Telephone:
|
9811552928 |
|
Email:
|
sanjivsaigal@hotmail.com |
|
Affiliation:
|
Institute of liver transplantation and regenerative medicine, |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients attending the outpatient clinics or inpatient services of the hospital and being worked up for liver transplantation will be included.
Patients who have undergone liver transplantation and return with liver injury (serum transaminase exceeding twice the upper limit of normal) will also be enrolled.
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- Patients planned for liver transplantation will be enrolled.
Patients who have previously undergone liver transplantation and develop liver enzyme abnormalities.
|
|
Primary Outcome(s)
|
To determine the frequency of HEV infection among
liver transplant recipients who are receiving Immunosuppression,
liver transplant recipients who return with liver enzyme elevation.Timepoint: 1 year
|
|
Secondary Outcome(s)
|
To determine the frequency of various HEV genotypes among above patients who are found to have HEV infection.
To look for evidence of chronic HEV infection among above patient groups.Timepoint: 1 year
|
|
Source(s) of Monetary Support
|
|
Medanta The Medicity,
Sector 38, Gurgaon-122001, Haryana, India
|
|
Ethics review
|
Status: Approved
Approval date: 08/04/2014
Contact:
Medanta Institutional Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|