Anonymous (PPI‐461) 2011a1

Methods	Randomised clinical trial
Participants	24 treatment‐naive participants were randomised Inclusion criteria: 18‐65 years male and female, genotype 1, treatment‐naive. Female participants must be surgically sterile or 2 years post‐menopausal and are required to take a pregnancy test. BMI 18‐32 kg/m2, chronically infected with HCV genotype 1. Serum HCV RNA > 5 log 10 IU/mL. No previous treatment with IFNIFN, peg‐IFN, RBV or any investigational HCV antiviral agents. No history or signs of decompensated liver disease. No known history of cirrhosis, no co‐infection with HBV or HIV. No history of any medical condition that may interfere with absorption, distribution or elimination of study drug or with the clinical and laboratory assessments in this study. No history of alcohol abuse, or illicit drug use within 2 years prior to screen or enrolment in a methadone maintenance programme (unless he/she has been enrolled in the programme for at least 3 months with good compliance, stable psychosocial circumstances and no known current risks for recidivism).
Interventions	Experimental group: 50 mg PPI‐461 once a day, 100 mg PPI‐461 once a day, 200 mg PPI‐461 once a day for 3 days Control group: placebo 2 weeks' follow‐up Co‐intervention: none
Outcomes	Primary outcomes: safety and tolerability as measured by clinical AE and laboratory assessments (time frame: up to study day 16, 14 days after the last dose of PPI‐461). Antiviral effects of PPI‐461 measured by HCV RNA levels and pharmacokinetics measured by plasma concentrations of PPI‐461 concentrations.
Notes	This is an unpublished study, only results from 2 abstracts
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 is described as double‐blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	No main publication, no drop‐outs
Selective reporting (reporting bias)	Unclear risk	Outcomes are only published in the protocol
Vested‐interest bias	High risk	Lead sponsor is Presidio Pharmaceuticals
Other bias	Low risk	The trial appeared to be free of other components that could put it at risk of bias