A strategic post-licensing trial of oral direct-acting antiviral hepatitis C treatment in VIETNam incorporating a novel design with multiple ARMS (VIETNARMS)

niversity of Oxford0 sites1,092 target enrollmentOctober 4, 2019

ConditionsHepatitis C virus (HCV) infection Infections and Infestations

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis C virus (HCV) infection
Sponsor: niversity of Oxford
Enrollment: 1092
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32423467/ protocol (added 26/05/2020)

Registry

who.int

Start Date

October 4, 2019

End Date

December 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•1\. Aged \=18 years
•2\. Prior evidence\* of HCV infection for more than 6 months AND at least one detectable (\>LLOQ) HCV viraemia within 60 days prior to the enrolment visit (by quantitative HCV RNA, qualitative assay or HCV genotype), with no subsequent undetectable results. This latter result may come from a sample taken at the screening visit.
•3\. Laboratory tests at the screening visit or within 60 days of enrolment/randomisation:
•3\.1\. Creatinine clearance (estimated using Cockcroft\-Gault) \=50 ml/min
•3\.3\. Haemoglobin \>8\.5 g/dl
•4\. Mild liver disease: No evidence of significant liver fibrosis resulting from any aetiology, defined as one of the following:
•4\.1\. Fibroscan\*\* score \=9 kPa, equivalent to F0\-F2, within 180 days prior to planned enrolment
•4\.2\. Biopsy consistent with mild fibrosis (Ishak score \=2/6\) within 180 days prior to planned enrolment
•5\. HIV\-uninfected or, if HIV\-infected, stable on antiretroviral therapy for \>6 months (not necessarily on same regimen throughout), with HIV viral load \<50 copies/ml at the screening visit, and currently taking HIV treatment compatible with all possible trial treatment options (SOF/DCV \+/\- RBV and SOF/VEL \+/\-RBV), with no requirement for study drug dose adjustment
•6\. HBsAg negative or, if HBsAg positive, then stable on tenofovir\-containing therapy\*\*\*

Exclusion Criteria

•1\. No previous hepatitis C treatment failure with DAA based therapy
•2\. Unidentified HCV genotype after repeated sequencing attempts
•3\. Any condition in the judgement of the investigator which might limit the participant’s life expectancy within the duration of the study (e.g. advanced hepatocellular carcinoma)
•4\. Any disorder or circumstance which in the opinion of the investigator may have a significant negative impact on the ability of the participant to adhere to the trial regimen
•5\. Disorder which may cause ongoing liver disease including, but not limited to, ongoing alcohol misuse
•6\. Currently receiving medication known to interact with study medications, for which avoidance of co\-administration or dose adjustment for SOF, DCV, VEL, RBV or PEG\-IFN, would be recommended in the Summary of Product Characteristics. This includes the antiretroviral (ARV) drugs efavirenz, atazanavir/ritonavir and zidovudine\*.
•7\. Participants currently using amiodarone or digoxin (including participants with permanent pacemakers)
•8\. History of severe pre\-existing cardiac disease, including unstable or uncontrolled heart disease, in the previous 6 months\*\*
•9\. Abnormal ECG finding at screening in a participant with pre\-existing mild\-moderate cardiac disease that in the opinion of the investigator means they should not be enrolled
•10\. Any pre\-existing condition that may be worsened by use of PEGylated\-interferon, including deranged thyroid function\*\*\*, autoimmune hepatitis, severe retinopathy\*\*\*\* and existence of, or history of severe psychiatric illness