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About
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Willing and able to provide written informed consent
Male or female, age ≥18 years
Chronic hepatitis C virus infection
Fatigue Impact Scale Score (FIS) >45 and a sum score (Att Test Sum Score) >0.4 in the battery of attention tests applied.
Female who is:
practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)
sexually active with female partners only
not of childbearing potential, defined as:
of childbearing potential and sexually active with male partner(s):
Females of childbearing potential must have negative results for pregnancy tests performed:
Males who are not surgically sterile and who are sexually active with female partner(s) of childbearing potential must agree to practice an effective form of birth control (see section 4.3) throughout the course of the study, starting with Study Day 1 and for 30 days after stopping study drug.
Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
Body Mass Index (BMI) is > 17 to < 40 kg/m2. BMI is calculated as weight measured in kg divided by the square of height measured in meters (m).
Confirmation of chronic genotype 1b HCV infection documented by the following:
Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening
Per local standard practice, documented results of:
HCV > RNA 1000 IU/ml at Screening
Subject must be of generally good health as determined by the Investigator.
Subject has not been treated with any investigational drug or device or any commercially available anti-HCV agents within 42 days of the Screening visit.
Exclusion criteria
Any previous exposure to HCV protease inhibitors, HCV NS5A inhibitors or HCV polymerase inhibitors
History of severe, life threatening or other significant sensitivity to any drug.
Pregnant or nursing female or male with pregnant female partner
Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
Infection with hepatitis B virus (HBV; defined as HBsAg-positive) or human immunodeficiency virus (HIV)
Use of any medication that are contraindicated for use with OBV/PTV/r and DSV within 2 weeks prior to study drug administration or 10 half-lives of the medication whichever is longer (see SmPC of OBV/PTV/r and DSV and section 4.4).
Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, and propoxyphene.
History of uncontrolled seizures, cancer (except basal cell carcinoma of the skin), or uncontrolled diabetes, as defined by a hemoglobin A1C level > 8.0% or other systemic diseases that affect directly the CNS and brain metabolites.
Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
Clinical hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
Solid organ transplantation.
Significant pulmonary disease or significant cardiac disease.
Significant drug allergy (such as anaphylaxis or hepatotoxicity).
Contraindications for MRI study
Screening laboratory analyses show any of the following abnormal laboratory results:
Screening ECG with clinically significant abnormalities
Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive the study medication
Donation or loss of more than 400 ml blood within 2 months prior to Baseline/Day 1
Primary purpose
Allocation
Interventional model
Masking
5 participants in 2 patient groups
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Central trial contact
Heiner Wedemeyer, Prof. Dr.; Markus Cornberg, Prof. Dr.
Data sourced from clinicaltrials.gov
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