MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV

Summary

This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to investigate whether a successful interferon-free treatment of HCV-infection with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves the patients' attention ability as compared to placebo as measured with the Att Test Sum Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be followed up for 48 weeks.

Timeline

Start

2017-10-24

Primary completion

2018-10-22

Completion

2018-10-22

Outcome

Outcome not reported

Stopped (Enrollment): “The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.”

Drugs

Indications