ISRCTN61522291进行中（未招募）2 期
A strategic post-licensing trial of oral direct-acting antiviral hepatitis C treatment in VIETNam incorporating a novel design with multiple ARMS (VIETNARMS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,092
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32423467/ protocol (added 26/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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***
- •7. Written informed consent obtained from the participant
- •*Evidence from clinical documentation, detected HCV antibody, HCV viraemia, qualitative viral RNA or HCV genotype.
- •** Fibroscan must be a valid result (based on at least 10 readings) performed by an experienced (as evidenced by CV and/or training logs) technician.
- •*** Participants co-infected with HCV and HBV fulfilling the standard criteria for HBV treatment and already commenced on treatment will continue to receive tenofovir treatment. Participants who are HBsAg positive but not requiring HBV treatment will commence tenofovir prophylaxis 1 week prior to DAA treatment, until 12 weeks after end of treatment, in keeping with EASL and local guidelines.
排除标准
- •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
- •11. Use of other investigational products in clinical studies within 60 days of screening
- •12. Pregnant or breastfeeding females, females planning pregnancy within 4 months of end of study, and males planning pregnancy with a female partner within 7 months of end of study
- •* HIV-infected individuals taking these medications may be included in the trial providing they can be switched to a suitable WHO-recommended ARV regimen. For example, efavirenz and atazanavir/ritonavir may be substituted with dolutegravir, raltegravir or lopinavir/ritonavir. Zidovudine may be substituted with tenofovir. Any switch should occur at least 1 month before randomisation, to ensure the new regimen is well-tolerated and the viral load remains suppressed. Participants requiring such a switch will continue on the new regimen for the duration of the trial. All ARV drug costs will be covered.
- •**Severe pre-existing cardiac disease defined as history of congestive heart failure, previous myocardial infarction, symptomatic angina in preceding 6 months, or life threatening arrhythmia (including complete heart block).
- •*** Participants with thyroid disease may be eligible providing any thyroid abnormalities (TSH, T4) are adequately controlled prior to initiation of treatment.
- •****All patients will undergo fundoscopy at screening by the study doctor. Patients with diagnosed or confirmed retinopathy at screening (including macular oedema, retinal artery or vein thrombosis, retinal haemorrhage, cotton wool spots, optic neuritis, papilloedema and retinal detachment) will be excluded from the trial if it is the opinion of the investigator that there is significant risk of this deteriorating if
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