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COMPLETEDPHASE2/PHASE3

8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C

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

NCT04885855•Muhammad Radzi Abu Hassan

View on ClinicalTrials.gov

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. All the recruited subjects will receive the treatment accordingly and be followed up for 24 weeks following the completion of treatment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Has evidence of chronic HCV infection, defined as:
•a. 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.
•2. Willing and able to provide written informed consent.
•3. Men and women age ≥ 18 years and \< 70 years.
•4. Body Mass Index (BMI) of 18 to 35 kg/m2.
•5. Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
•6. Women with a negative pregnancy test at screening and baseline assessment.
•7. 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.
•8. 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.
•9. HIV/HCV co-infected patients receiving cART fulfilling the below criteria are eligible for the study:
+6 more criteria

Exclusion Criteria

•1. Has evidence of liver cirrhosis in which, liver cirrhosis is determined by;
•1. APRI score of ≥ 1.5,
•2. 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
•3. Current/past history of decompensation including ascites, variceal bleeding, bacterial peritonitis, or hepatic encephalopathy.
•1. Direct bilirubin \>3x ULN
•2. AST, ALT \>10x ULN
•3. Low neutrophil count (≤599 cells/mm3), haemoglobin (\<9.0 g/dL), platelets (\<150000 cells/mm3).
•3. Patients with serum creatinine \>1.5 ULN or end-stage renal disease.2
+11 more criteria

Locations (1)

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Key Dates

Start Date

March 23, 2021

Primary Completion Date

December 29, 2023

Completion Date

March 15, 2024

Last Updated

March 13, 2025

Enrollment

322

ACTUAL participants

Conditions

Hepatitis C

Interventions

Sofosbuvir 400 MG

DRUG

Ravidasvir 200mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C

Inclusion Criteria

Exclusion Criteria

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