Hepatitis CPhase 2/3NCT04885855
8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C
A Phase 2/3 study testing Sofosbuvir 400 MG and Ravidasvir 200mg in people with Hepatitis C, run by Muhammad Radzi Abu Hassan at 1 site in Malaysia.
Trial summary
This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir 400 MG and Ravidasvir 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Mar 2021to 15 Mar 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has evidence of chronic HCV infection, defined as:
- Positive anti-HCV antibody or detectable HCV RNA or HCV genotype and HCV viral load ≥104 IU/mL within 6 months prior to the time of blood collection for screening.
- Willing and able to provide written informed consent.
- Men and women age ≥ 18 years and < 70 years.
- Body Mass Index (BMI) of 18 to 35 kg/m2.
- Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
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- Women with a negative pregnancy test at screening and baseline assessment.
- Women of childbearing potential who accept effective contraception from 2 weeks prior to day 1 of study to 1 month after treatment (double contraceptive method including at least one barrier method). A woman is of non-childbearing potential if she (a) reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b) had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy.
- Subjects who are compliant in opioid substitution maintenance program may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules.
- HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study:
- Antiretroviral therapy has been initiated at least 6 months prior to screening (to avoid the possibility of Immune reconstitution inflammatory syndrome - IRIS)
- Patient has been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study.
- HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert
- Screening HIV RNA <50 copies/mL.
- Screening CD4 cell count ≥100 cells/uL
- HIV/HCV co-infected patients not receiving cART: Screening CD4 cell count must be ≥ 500 cells/uL
Who cannot join
- Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
- APRI score of ≥ 1.5,
- In case where APRI score is >1.0 but <1.5,
- Perform fibroscan* (where TE ≥12.5 kPa indicates liver cirrhosis) or
- Calculate FIB-4 index (where ≥3.25 indicates liver cirrhosis) *Depending on availability at facility
- Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
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- Additional laboratory exclusion criteria:
- Direct bilirubin >3x ULN
- AST, ALT >10x ULN
- Low neutrophil count (≤599 cells/mm3), haemoglobin (<9.0 g/dL), platelets (<150000 cells/mm3).
- Patients with serum creatinine >1.5 ULN or end-stage renal disease.2
- Hepatitis B co-infection (HBsAg positive).
- Pregnancy, as documented by positive pregnancy tests at screening and baseline assessment.
- Breastfeeding.
- Subjects currently receiving or unable to stop the use for at least 1 week prior to receiving the first dose of study drug any medications or herbal supplements known to be potent inhibitors or moderate inducers of cytochrome P450 (CYP) 3A4 and potent inducers of P-glycoprotein. This includes subjects who are on amiodarone or other contraindicated drugs. Refer to www.hep_druginteractions.org, the investigator manual and the investigator's brochure for detailed information.
- Participation in other clinical trials within 3 months.
- Any clinically significant findings or unstable condition during the screening, medical history or physical examination that, in the investigator's opinion, would compromise participation in this study. This could include patients with poorly controlled hypertension, asthma, diabetes, or other life-threatening conditions.
- Current or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents. Corticosteroid used to treat any medical condition are allowed if systemic for not more than 2 weeks or if topical.
- History of solid organ or bone marrow transplantation.
- Any prior DAA use or NS5A inhibitors therapy.
- Patients with significant cardiovascular conditions including myocardial infarction within the previous 6 months or heart failure NYHA class III or IV; history of Torsade de pointes
- HIV/HCV co-infected patients who are yet to receive stable antiretroviral therapy or for whom ART treatment initiation maybe scheduled during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia
This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients.
All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir 400 MG, Ravidasvir 200mg
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir 400 MGDrug
Also called Grateziano
Sofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B)
Ravidasvir 200mgDrug
Also called PPI-668
Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A)
| Study group | Role | What they receive |
|---|---|---|
| 8-week | Experimental | Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 8 weeks. Receives: Drug: Sofosbuvir 400 MG; Drug: Ravidasvir 200mg |
| 12-week | Active comparator | Patient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 12 weeks. Receives: Drug: Sofosbuvir 400 MG; Drug: Ravidasvir 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Sustained Virological Response (SVR) at week-12 post treatment, as evidenced by Hepatitis C Viral (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification of 15 IU/mL.
Measured: 12 weeks upon completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start23 Mar 2021
- Primary completion29 Dec 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Radzi Abu Hassan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Muhammad Radzi Abu Hassan, Hospital Sultanah Bahiyah
- Investigators
- Muhammad Radzi Abu Hassan, FRCP, Principal investigator, Hospital Sultanah Bahiyah, Ministry of Health Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885855
- Sponsor's protocol ID
- MOH-8v12-SOF/RDV-01-HCV
- Status last verified
- Mar 2025
- First submitted
- 9 May 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhamad NA, Mohd Dali NS, Maamor NH, Rosli IA, Leman FN, Awaluddin SM, Chan HK, Mohd Zin R, Abu Hassan MR. Time to viral load suppression with 8-week versus 12-week ravidasvir/sofosbuvir regimens among chronic hepatitis C patients in Malaysia: a non-inferiority, randomized clinical trial. BMC Infect Dis. 2026 Jun 11. doi: 10.1186/s12879-026-13741-5. Online ahead of print.
PubMed 42277657Abu Hassan MR, Muhamad NA, Mohammed NS, Mohd Suan MA, Zulkifli Supramaniam DN, Jogulu SR, Md Salleh MF, Soelar SA, Rosli IA, Leman FN, Mohd Dali NS, Maamor NH, Ngah NF, Chan HK; EASE Trial Group. A Multicenter, open-label, randomized, non-inferiority trial of 8 versus 12 weeks of sofosbuvir/ravidasvir treatment in non-cirrhotic patients with chronic hepatitis C virus infection (EASE trial). Int J Infect Dis. 2026 Aug;169:108788. doi: 10.1016/j.ijid.2026.108788. Epub 2026 May 14.
PubMed 42140479
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia
- ClinicalTrials.gov ID
- NCT04885855
- Acronym / sponsor ID
- MOH-8v12-SOF/RDV-01-HCV
- Conditions
- Hepatitis C
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Muhammad Radzi Abu HassanOther government
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is open-label, randomized, multicentre study to compare the efficacy and safety of the 8-week versus 12-week of SOF-RVD combination treatment for non-cirrhotic chronic hepatitis C patients.
All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-week | Experimental | Drug: Sofosbuvir 400 MG, Drug: Ravidasvir 200mgPatient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 8 weeks. |
| 12-week | Active comparator | Drug: Sofosbuvir 400 MG, Drug: Ravidasvir 200mgPatient will be receiving treatment of tablet Sofosbuvir 400mg and tablet Ravidasvir 200mg combination once daily for the duration of 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Has evidence of chronic HCV infection, defined as:
- Willing and able to provide written informed consent.
- Men and women age ≥ 18 years and < 70 years.
- Body Mass Index (BMI) of 18 to 35 kg/m2.
- Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
Key exclusion criteria (22 listed)
- Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
- Additional laboratory exclusion criteria:
- Patients with serum creatinine >1.5 ULN or end-stage renal disease.2
- Hepatitis B co-infection (HBsAg positive).
- Pregnancy, as documented by positive pregnancy tests at screening and baseline assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir 400 MGAlso: GratezianoSofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B) | Drug | 12-week, 8-week |
| Ravidasvir 200mgAlso: PPI-668Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A) | Drug | 12-week, 8-week |
Primary outcome
SVR12
Time frame: 12 weeks upon completion of treatment
Sustained Virological Response (SVR) at week-12 post treatment, as evidenced by Hepatitis C Viral (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification of 15 IU/mL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 42277657Muhamad NA, Mohd Dali NS, Maamor NH, Rosli IA, Leman FN, Awaluddin SM, Chan HK, Mohd Zin R, Abu Hassan MR. Time to viral load suppression with 8-week versus 12-week ravidasvir/sofosbuvir regimens among chronic hepatitis C patients in Malaysia: a non-inferiority, randomized clinical trial. BMC Infect Dis. 2026 Jun 11. doi: 10.1186/s12879-026-13741-5. Online ahead of print.
- Derived from this study: PubMed 42140479Abu Hassan MR, Muhamad NA, Mohammed NS, Mohd Suan MA, Zulkifli Supramaniam DN, Jogulu SR, Md Salleh MF, Soelar SA, Rosli IA, Leman FN, Mohd Dali NS, Maamor NH, Ngah NF, Chan HK; EASE Trial Group. A Multicenter, open-label, randomized, non-inferiority trial of 8 versus 12 weeks of sofosbuvir/ravidasvir treatment in non-cirrhotic patients with chronic hepatitis C virus infection (EASE trial). Int J Infect Dis. 2026 Aug;169:108788. doi: 10.1016/j.ijid.2026.108788. Epub 2026 May 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Radzi Abu Hassan, FRCP principal investigator
Hospital Sultanah Bahiyah, Ministry of Health Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sofosbuvir 400 MG and Ravidasvir 200mg in people with Hepatitis C, run by Muhammad Radzi Abu Hassan at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: 12 weeks upon completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.