Methods | Randomised clinical trial | |
Participants | 10 adult participants Inclusion criteria: with diagnosis of cirrhosis and chronic HCV (genotype 1) infection with a VL greater than 50,000 copies mRNA/ml serum. Country: Germany |
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Interventions |
Experimental group: oral 200 mg twice daily for 2 days. Control group: placebo. |
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Outcomes | Efficacy assessment, safety assessment | |
Notes | Unpublished data only | |
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 double‐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 double‐blinded but it was unclear how the blinding was performed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained |
Vested‐interest bias | High risk | The trial was funded by Boehringer Ingelheim |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias |