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