Methods | Randomised clinical phase II trial | |
Participants | 24 adults with chronic hepatitis C, genotype 1, who were naive to antiviral treatment. Country: Thailand Exclusion criteria: not described. |
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Interventions |
Experimental group: oral 200 mg, 400 mg of BIT225 for 28 days. Control group: placebo. Co‐intervention: IFN alfa 2b and RBV for a total of 48 weeks. |
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Outcomes | SVR, safety, pharmacokinetics. | |
Notes | ||
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 | The trial was described as being placebo‐blinded, but it was unclear how the blinding was performed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial was described as being placebo‐blinded, but it was unclear how the blinding was performed |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No data |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained |
Vested‐interest bias | High risk | The trial was funded by Bristol‐Myers Squibb |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |