Methods | Randomised clinical trial | |
Participants | 64 participants Mean age: 50 years Country: USA Inclusion criteria: treatment‐naive adult participants with chronic hepatitis C. |
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Interventions |
Experimental group: oral 200 mg, 400 mg, 800 mg of ACH‐1625 for 28 days. Control group: placebo. Co‐intervention: peg‐IFN‐α 2a/RBV. |
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Outcomes | Pharmacokinetics, HCV RNA, safety assessment. | |
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 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 placebo‐blinded but it was unclear how the 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 | Unclear risk | Not described |
Other bias | Low risk | The trial appeared to be free of other bias domains that could put it at risk of bias |