| CTRI Number |
CTRI/2025/10/096378 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Phase 3 Trial Comparing BEM/RZR to SOF/VEL in Patients with Hepatitis C Virus Infection |
|
Scientific Title of Study
|
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-521096-31-00 |
EudraCT |
| AT-01B-008 Version 2.0 (Amendment 1) dated 01 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Pradhan |
| Designation |
Head Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,
Bangalore
KARNATAKA
560103
India |
| Phone |
9513774664 |
| Fax |
|
| Email |
shweta.pradhan@iqvia.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Pradhan |
| Designation |
Head Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli,
KARNATAKA
560103
India |
| Phone |
9513774664 |
| Fax |
|
| Email |
shweta.pradhan@iqvia.com |
|
|
Source of Monetary or Material Support
|
| Atea Pharmaceuticals, Inc.
225 Franklin Street
Suite 2100
Boston, MA 02110 USA
|
|
|
Primary Sponsor
|
| Name |
Atea Pharmaceuticals, Inc. |
| Address |
225 Franklin Street
Suite 2100
Boston, MA 02110 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| IQVIA RDS INDIA PRIVATE LIMITED |
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103
|
|
|
Countries of Recruitment
|
Egypt
France
Germany
Greece
India
Malaysia
Pakistan
Poland
Republic of Korea
Republic of Moldova
Romania
South Africa
Spain
Thailand
Turkey
Viet Nam |
|
Sites of Study
|
| No of Sites = 21 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shine Sadasivan |
Amrita Institute of Medical Sciences Healthcare |
Department of Gastroenterology, Education and Research, AIMS-Ponekkara, PO, Kochi-682041
Ernakulam
KERALA |
9497556339
shines1560@aims.amrita.edu |
| Dr Brij Sharma |
Atal Institute of Medical Super Specialities |
Department of Gastroenterology, Shimla - 171006
Shimla
HIMACHAL PRADESH |
9418587487
drbrijsharma01@gmail.com |
| Dr Pravin Motilal Rathi |
B. Y. L. Nair Charitable Hospital & Topiwala National Medical College |
7th Floor, Department of Gastroenterology, College Building, A. L. Nair Road, Mumbai Central,400008
Mumbai
MAHARASHTRA |
9322406438
nairgastroenterology@gmail.com |
| Dr Dawesh Prakash Yadav |
Banaras Hindu University |
Department of Gastroenterology, Institute of Medical Sciences, Varanasi - 221005
Varanasi
UTTAR PRADESH |
8130856563
dr.dawesh.ct@gmail.com |
| Dr Omesh Goyal |
Dayanand Medical College and Hospital |
Civil Lines, Tagore Nagar, Ludhiana - 141001
Ludhiana
PUNJAB |
9918421155
dr_omesh_goyal@dmch.edu |
| Dr Sachin Sudhakarroa Palnitkar |
Deenanath Mangeshkar Hospital and Research Centre |
Off Karve Road, Erandawane, 411004
Pune
MAHARASHTRA |
9966789779
palnitkarsachin@gmail.com |
| Dr Vinay Kumar |
G. S. V. M. Medical College |
Post Graduate Department of Medicine, Swaroop Nagar, Kanpur - 208002
Kanpur Nagar
UTTAR PRADESH |
8004877113
dr.vinaysachan@gmail.com |
| Dr Saumin Prakashbhai Shah |
Gujarat Gastro and Vascular Hospital |
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan, Surat - 395009
Surat
GUJARAT |
9408042224
dr.sauminpshah@gmail.com |
| Dr Manish Mandal |
Indira Gandhi Institute of Medical Sciences |
Department of Gastroenterology , Sheikhpura, Patna - 800014
Patna
BIHAR |
9473191826
manishmandal5661@gmail.com |
| Dr Abhijit Chowdhury |
John C Martin Centre for Liver Research and Innovations |
Centre for Clinical Research, John C. Martin Centre for Liver Research and Innovations Affiliated Hospital, Institute of Liver & Digestive Sciences Campus, Sitala East, Sonarpur, 700150
Kolkata
WEST BENGAL |
9433045435
achowdhury2002@yahoo.co.in |
| Dr Santosh Dhananjay Hajare |
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department of Gastroenterology, J. N. Medical College, Nehru Nagar, Belgaum - 590010
Belgaum
KARNATAKA |
9448111913
drsantoshhajare@gmail.com |
| Dr Vineet Kumar Shukla |
KRM Hospital & Research Centre |
3/92-93, Vijayant Khand Gomati Nagar, Lucknow-226010
Lucknow
UTTAR PRADESH |
7905304034
vineetshukla38@gmail.com |
| Dr Sachin Kisan Shivnitwar |
Lifepoint Multispeciality Hospital |
Sr. No. 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Bhumkar Chowk, Wakad, 411057
Pune
MAHARASHTRA |
8999285166
sachinshivnitwar94@gmail.com |
| Dr Shrikant Vasantrao Mukewar |
Midas Hospital |
392, Parsodi, Wardha Road, Nagpur 441108
Nagpur
MAHARASHTRA |
7720033280
shrikant_mukewar@yahoo. com |
| Dr Jayanta Samanta |
Postgraduate Institute of Medical Education and Research |
Department of Gestroentrology, F- Block, Ground Floor, Nehru Hospital, Sector-12, 160012
Chandigarh
CHANDIGARH |
9227132025
dj_samanta@yahoo.co.in |
| Dr Hemant Kumar Gupta |
Samvedna Hospital |
B-27/88G, New Colony, Ravindrapuri, Varanasi - 221005
Varanasi
UTTAR PRADESH |
8573888800
hemantkrg26@gmail.com |
| Dr Prabhat Kumar Agrawal |
Sarojini Naidu Medical College |
Central Library, Moti Katra, Agra - 282003
Agra
UTTAR PRADESH |
9319250485
ppagrawal120@gmail.com |
| Dr Arun Vaidya |
Seth G. S. Medical College and King Edward Memorial Hospital |
Department of Gastroenterology Acharya Donde Marga, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9699044016
arunvaidyagastro@gmail.com |
| Dr Chetan Nalin Mehta |
Shree Giriraj Multispeciality Hospital |
A unit of Shree Giriraj Lifecare Pvt Ltd, 27-Navjyot Park, 150 Feet Ring Road, Rajkot - 360005
Rajkot
GUJARAT |
9825077472
mehtacn@hotmail.com |
| Dr Rajiv Manhar Mehta |
SIDS Hospital & Research Centre |
Surat Institute of Digestive Sciences, Vijay Nagar, Gate No-3, Besides Nirman Bhavan, Opp Gandhi College, Majura Gate, Ring Road, Surat-395002
Surat
GUJARAT |
9879863510
rmgastro@yahoo.com |
| Dr B Ravi Shankar |
Yashoda Hospitals |
Department of Gastroenterology, Yashoda Healthcare Services PVT. LTD, SP Road, Behind Hari Hara Kala Bhavan, Secunderabad - 500003
Hyderabad
TELANGANA |
9391075600
b_ravishankar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 21 |
| Name of Committee |
Approval Status |
| Drug Trial Ethics Committee Dayanand Medical College and Hospital |
Submittted/Under Review |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE |
Approved |
| Human Research Ethics Committee Institute of Liver & Digestive Sciences |
Approved |
| Institutional Ethics Committee, KLE Academy of Higher Education and Research |
Submittted/Under Review |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre |
Submittted/Under Review |
| Institutional Ethics Committee, Atharva Multispeciality Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Center |
Submittted/Under Review |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Indira Gandhi Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Midas Multispeciality Hospital Pvt. Ltd |
Submittted/Under Review |
| Institutional Ethics Committee, S N Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, Topiwala National Medical College Nair Hospital |
Submittted/Under Review |
| Institutional Ethics Committee-l,Seth GS Medical College and KEM Hospital |
Submittted/Under Review |
| Lifepoint Research- Ethics Committee |
Approved |
| Post Graduate Institute of Medical Education and Research |
Submittted/Under Review |
| Samvedna Hospital Ethics Committee |
Approved |
| Shree Giriraj Hospital Research Ethics Committee |
Submittted/Under Review |
| Surat Institute of digestive sciences |
Approved |
| Unity Hospital Ethics Committee, Unity Trauma Center And ICU |
Approved |
| Yashoda Academy of Medical Education and Research |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B182||Chronic viral hepatitis C, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bemnifosbuvir/Ruzasvir |
275 mg/90 mg
Dose: once daily
Route: Oral Fixed Dose Combination (FDC) tablets
Duration: 8 (without cirrhosis) or 12 weeks (with compensated cirrhosis)
|
| Comparator Agent |
Sofosbuvir and Velpatasvir |
400 mg/100 mg
Dose: once daily
Route: Oral Fixed Dose Combination (FDC) tablets
Duration: 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Use of adequate contraception for females of childbearing potential
2 Must be direct acting antiviral (DAA) treatment naïve (never exposed to an approved or experimental DAA for HCV)
3 Documented medical history compatible with chronic HCV
4 Either no liver cirrhosis or with compensated liver cirrhosis
5 If HIV-1-positive, must meet the following 2 criteria:
i. Antiretroviral (ARV) regimen for more than 8 weeks prior to screening visit, with CD4 T-cell count more than 200 cells/mm3 and plasma HIV-1 RNA less than LLOQ
ii. Suitable ARV treatment and not taking any contraindicated medications
|
|
| ExclusionCriteria |
| Details |
1 Pregnant or breastfeeding
2 Co-infected with hepatitis B virus
3 Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
4 Requirement of any prohibited medications
5 Use of other investigational drugs within 30 days of dosing
6 History or signs of decompensated liver disease (decompensated cirrhosis)
7 History of hepatocellular carcinoma (HCC)
8 Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD |
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of RASs in NS5A and/or NS5B on the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD |
Proportion of subjects with baseline RASs in NS5A & NS5B who achieved SVR at Weeks 24 & 36 |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
29/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AT-01B-008 is a randomized, controlled, open-label, phase 3 study to compare the efficacy of a fixed dose combination of bemnifosbuvir or ruzasvir after 8 weeks in those without cirrhosis or 12 weeks in those with compensated cirrhosis of once daily treatment versus standard of care sofosbuvir or velpatasvir FDC after 12 weeks of daily treatment in subjects with chronic HCV infection. The primary objective of the study is to evaluate the efficacy of bemnifosbuvir or ruzasvir as fixed dose combination administered for 8 or 12 weeks versus sofosbuvir or velpatasvir FDC administered for 12 weeks. Approximately 880 subjects will be randomized 1 to 1 and stratified by cirrhosis and genotype in the main study. There will be an optional PK sub-study conducted on approximately 50 subjects who receive bemnifosbuvir or ruzasvir and provide consent to participate. Patients in India enrolled in the trial will be given the option to participate in the PK sub study. An independent Data Safety Monitoring Board will review safety and efficacy data during the course of the study, as described in the DSMB charter, to evaluate continued benefit or risk of subjects enrolled in the study. |