| CTRI Number |
CTRI/2022/03/041368 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of eight weeks of treatment for chronic hepatitis C virus infection |
|
Scientific Title of Study
|
REduced duration of Eight versus twelVe weeks of SOfosbuvir-VeLpatasvir in treatment naive non-cirrhotic patients with chronic hepatitis C virus infection: A Multicentric, Open labeled, Randomized, Non-inferiority trial |
| Trial Acronym |
RESOLVE trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC Code: 2021-310-EMP-124 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Goel |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Gastroenterology, SGPGI
Department of Gastroenterology, SGPGI
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Goel |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Gastroenterology, SGPGI
Department of Gastroenterology, SGPGI
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Goel |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) |
| Address |
Department of Gastroenterology, SGPGI
Department of Gastroenterology, SGPGI
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
09936275741 |
| Fax |
|
| Email |
agoel.ag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research-Indian Council of Medical Research, New Delhi, India (Proposal ID: 2021-1076) |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalimar |
AIIMS, New Delhi |
Department of Gastroenterology, All India Institute of Medical Sciences
New Delhi
DELHI |
9968405815
drshalimar@gmail.com |
| Dr Vinod Kumar |
BHUIMS |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, India
Varanasi
UTTAR PRADESH |
9984719346
drv_inod@yahoo.co.in |
| Dr Ajay Kumar |
GBPH |
Department of Gastroenterology,
Govind Ballabh Pant Institute of
Postgraduate Medical Education and
Research, New Delhi
New Delhi
DELHI |
9968147901
ajaykumar.aiims@gmail.com |
| Dr Sumit Rungta |
KGMU |
Department of Gastroenterology, King Georgee Medical University
Lucknow
UTTAR PRADESH |
9935537944
drsumitrungta79@gmail.com |
| Dr Amit Goel Additional Professor |
SGPGI |
Department of Gastroenterology, SGPGI, Lucknow
Lucknow
UTTAR PRADESH |
91993627574
agoel.ag@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethic Committee |
Approved |
| IMS BHU Institute Ethic Committee |
Approved |
| MAMC Institute Ethic Committee |
Approved |
| Scientific Review Committee, KGMU |
Approved |
| SGPGI Institute Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K738||Other chronic hepatitis, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sof-Vel eight weeks |
Sofosbuvir plus velpatasvir combination for a duration of eight weeks |
| Comparator Agent |
Sof-Vel twelve weeks |
Sofosbuvir plus velpatasvir combination for a duration of twelve weeks |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >18 years
2. HCV mono-infection or HCV-HIV coinfection
3. Detectable HCV RNA (>10,000 IU/mL) in serum
4. Chronic HCV infection
5. No evidence of cirrhosis based upon a combination of history, examination, ultrasound, Transient elastography, APRI, FIB-4, Upper GI endoscopy
|
|
| ExclusionCriteria |
| Details |
1. Presence of cirrhosis
2. HCV-HBsAg coinfection
3. Prior exposure to oral anti-HCV drugs, i.e, DAAs
4. Hepatocellular carcinoma or any other malignancy
5. Portal vein thrombosis
6. High-risk population such as people on maintenance hemodialysis, talassaemic or haemophiliacs, people who inject drugs, men have sex with men, high risk sexual behaviour
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir |
Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of participants who have completed their planned anti-HCV treatment |
Eight (intervention arm) or twelve weeks (standrad arm) after start of anti-HCV drugs |
|
|
Target Sample Size
|
Total Sample Size="880"
Sample Size from India="880"
Final Enrollment numbers achieved (Total)= "880"
Final Enrollment numbers achieved (India)="880" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2022 |
| Date of Study Completion (India) |
10/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Awasthi A, Katiyar H, Rungta S, Deep A, Kumar V, Shalimar, Kumar A, Tiwari P, Goel A. Eight versus twelve weeks of sofosbuvir-velpatasvir in treatment-naïve non-cirrhotic patients with chronic hepatitis C virus infection: Study protocol for a multicentric, open labelled, randomized, non-inferiority trial (RESOLVE trial). PLoS One. 2023 May 18;18(5):e0285725. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
HCV is a hepatotropic virus and all those with active HCV infection have need treatment. Though, several pangenotypic drug combinations are approved for HCV treatment, India has access to only two of them- sofosbuvir/daclatasvir and sofosbuvir/velpatasvir. Use of either of these combinations need 12 weeks of treatment. Recent studies have shown that the treatment duration can be reduced for from 12 weeks to 8 weeks for several anti-HCV drug combinations without compromising the response. The data are limited on effectiveness of 8 weeks of sofosbuvir/velpatasvir combination. Research question Can anti-HCV treatment duration be reduced from 12 weeks to 8 weeks without compromising the virological response? The primary objective is to compare the sustained virological response at week 12 (SVR12) after stopping 8 weeks or 12 weeks of sofosbuvir/velpatasvir in non-cirrhotic patients with chronic hepatitis C virus infection. The secondary objective is to compare the proportion of participants completing their planned 8 weeks or 12 weeks of treatment. Methodology This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 x 440) treatment naïve, viraemic, non-cirrhotic HCV patients. Participants will be randomized to receive either 8- or 12-week treatment followed by HCV RNA testing at 12 weeks after treatment completion for sustained virological response (SVR12) to define treatment success or failure. A blood specimen will be collected at baseline (for HCV genotype determination) and at 4 weeks of treatment (for early virological response).
Proposed outcome
The study will provide data on the efficacy of 8 weeks of treatment as compared to standard of care (12 weeks) in non-cirrhotic patients with active HCV infection. |