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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
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.
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.
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