Methods | Randomised clinical trial | |
Participants | An unknown amount of participants Sex: unknown Mean age: unknown Inclusion criteria: chronic HCV infection (> 6 months) and were treatment‐naive. Participants aged 18‐64 years with ≥ 104 IU/mL HCV RNA levels were enrolled in sequential, ascending dose cohorts of up to 16 participants (12 active, 4 placebo) per cohort. |
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Interventions |
Experimental group: participants received 50, 100, 250, 500, 1000, or 1500 mg oral doses of HCV‐796 or placebo given as monotherapy twice daily. Control group: placebo twice a day. Co‐intervention: none. |
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Outcomes | Most frequent AE, dose‐limiting toxicities or serious treatment‐emergent AEs, PK parameters, maximal antiviral effects. | |
Notes | The authors were contacted on VIROPHARMA all bias domains, mortality, SAE, SVR24. mean age, male:female, number of participants, final publication. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with incomplete data was not described |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained |
Vested‐interest bias | Unclear risk | It was unclear how the trial was funded |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |