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

NCT03003338 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

OBV/PTV/r and DSV

OBV/PTV/r (12.5 mg/ 75 mg/ 50 mg) in combination with DSV (250 mg): Two tablets of OBV/PTV/r in the morning and one tablet of DSV in the morning and one tablet of DSV in the evening orally with a meal without regard to fat or calorie content.

DRUG

Placebo to match OBV/PTV/r and DSV

Placebo to match OBV/PTV/r and DSV

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Heiner Wedemeyer, Prof. Dr. · Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2018-10-22
Completion
2018-10-22

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003338 on ClinicalTrials.gov