Methods | Randomised clinical trial | |
Participants | 18 participants Sex: 10 men, 8 women Mean age: 44 years Inclusion criteria: participants chronically infected with hepatitis C virus genotype 1, treatment‐naive or treatment non‐responders or treatment intolerant; and not co‐infected with HIV or HBV, HCV‐RNA viral load of ≥ 10*5* IU/mL and had a BMI 18‐35 kg/m² Exclusion criteria: any significant acute or chronic medical illness which was not stable or not controlled with medication and not consistent with HCV infection and major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug |
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Interventions |
Experimental group:
Control group: placebo |
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Outcomes | Pharmacokinetics, antiviral activity, safety. | |
Notes | We contacted trial authors for additional information on allocation sequence generation and concealment, how was blinding maintained, whether HIV participants included. | |
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 | Described as double‐blinded but the placebo was not described in detail |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | More than 5% of participants dropped out and it was unclear how the trial handled missing data |
Selective reporting (reporting bias) | Low risk | All the outcomes stated in the protocol were reported on NCT00546715 |
Vested‐interest bias | Unclear risk | The trial was funded by a company that might have an interest in a given result (Bristol‐Myers Squibb) |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |