| CTRI Number |
CTRI/2018/06/014408 [Registered on: 05/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
13/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the Efficacy of Directly Acting Antivirals In Patients of Hepatitis C Infection who are On Dialysis. |
|
Scientific Title of Study
|
A Prospective Observational Study of Efficacy and Safety of Directly Acting Antivirals in Chronic Kidney Patients on Maintenance Hemodialysis with Chronic Hepatitis C Virus Infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K N Singh |
| Designation |
Consultant Nephrology |
| Affiliation |
Indraprastha Apollo Hospital |
| Address |
Indraprastha Apollo Hospital
SARITA VIHAR, DELHI MATHURA ROAD, NEW DELHI - 110076, INDIA
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
drKnsinghnephro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Gote |
| Designation |
DNB Nephrology Registrar |
| Affiliation |
Indraprastha Apollo Hospital |
| Address |
Indraprastha Apollo Hospital
SARITA VIHAR, DELHI MATHURA ROAD, NEW DELHI - 110076, INDIA
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
Pankajgote@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Gote |
| Designation |
DNB Nephrology Registrar |
| Affiliation |
Indraprastha Apollo Hospital |
| Address |
Indraprastha Apollo Hospital
SARITA VIHAR, DELHI MATHURA ROAD, NEW DELHI - 110076, INDIA
New Delhi
DELHI
110076
India |
| Phone |
|
| Fax |
|
| Email |
Pankajgote@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDRAPRASTHA APOLLO HOSPITAL,
Sarita Vihar, Delhi Mathura Road, New Delhi - 110076 |
|
|
Primary Sponsor
|
| Name |
INDRAPRASTHA APOLLO HOSPITAL |
| Address |
Sarita Vihar, New Delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| K N SINGH |
INDRAPRASTHA APOLLO HOSPITAL |
Nephrology Department,Sarita Vihar, Delhi Mathura Road, New Delhi - 110076
New Delhi
DELHI |
9811471820
drknsinghnephro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Clinical Studies, Indraprastha Apollo Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Kideny Disease Patients on Hemodialysis With Hepatitis C infection, (1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic Kidney Disease on Hemodialysis with
concomitant Hepatitis C infection with or without compensated Liver Cirrhosis |
|
| ExclusionCriteria |
| Details |
Patients with Decompensated Liver Cirrhosis
2) Patients with Significant alcohol intake history
3) Concomitant Chronic Hepatitis B infection or HIV infection
4) NASH
5) Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients achieving the Sustained Virological response at 12
weeks post therapy |
12 weeks post therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To find out percentage of patients achieving the Virological response at end of
therapy
b) To find the incidence of adverse events of directly acting antivirals in patients with
Chronic kidney disease on Haemodialysis |
At end of 12 week of therapy |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/06/2017 |
| Date of Study Completion (India) |
30/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be a single center, prospective, observational study of “Efficacy and safety of directly acting antivirals in Chronic kidney disease patients on maintenance hemodialysis with Chronic hepatitis C virus infection.†It will be conducted at Indraprastha Apollo hospital, New Delhi for a period of 2 years between June 2017 and May 2019. Only patients with chronic renal disease stage V who are on hemodialysis and having Chronic hepatitis C with or without compensated cirrhosis will be taken. These patients then will be evaluated and will be treated for chronic hepatitis C infection with the new directly acting antivirals (DAAs).
Patients will be followed up during the treatment period (12 weeks) and up to 12 weeks post-treatment. Overall efficacy of directly acting antivirals in achieving the virological response at end of the treatment and sustained virological response at 12 weeks post-treatmentwill be assessed. Patients will also be interviewed and evaluated for adverse effects of DAAs. |