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

Hepatitis C, Chronic Clinical Trial

Official title:
A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03003338
Study type Interventional
Source Hannover Medical School
Contact
Status Terminated
Phase Phase 4
Start date October 24, 2017
Completion date October 22, 2018
View Details
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