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. 2017 Jun 6;2017(6):CD012143. doi: 10.1002/14651858.CD012143.pub2
Methods Randomised clinical trial
Participants 33 participants
Sex: 28 men, 5 women
Mean age: not described.
Inclusion criteria: treatment‐naive and treatment‐experienced noncirrhotic participants,18‐55 years old, with high viral load, genotype 1, chronic HCV infection.
Interventions Experimental group: oral 125 mg, 600 mg of MK‐7009 once daily for 8 days or 25 mg, 75 mg, 250 mg, or 500 mg of MK‐7009 twice daily for 8 days.
Control group: placebo.
Outcomes HCV RNA, safety assessment.
Notes We emailed Lawitz and colleagues on 26 April 2016 for additional information on random, blinding, missing data, protocol, data, participants' characteristics, funding, number of participants in placebo/exp group but reply not received yet.
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 placebo‐blinded, but it was not described how blinding was performed
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Described as placebo‐blinded, but it was not described how blinding was performed
Incomplete outcome data (attrition bias) All outcomes Unclear risk Not described
Selective reporting (reporting bias) Unclear risk No protocol could be obtained
Vested‐interest bias High risk Several authors worked for several pharmaceutical companies
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias