Technology-Based Application To Improve The Triple Therapy Adherence Rate In Subjects With Hepatitis C Infection

Withdrawn before enrolling · Not applicable

Conditions studied: Hepatitis C

In brief

No more than 56% of subjects at the Robley Rex Louisville Veterans Administration Medical Center (VAMC) prescribed boceprevir-based triple therapy, will complete Hepatitis C (HCV) treatment as prescribed. Of patients who did not complete therapy, the primary reasons for discontinuation were side effects (48%) and non-adherence (32%). An intervention is needed to improve the treatment completion rate in subjects so they can achieve the high SVR rates noted in SPRINT-2 and RESPOND-2

Key facts

Study ID: NCT02070107
Run by: University of Louisville
People needed: 0
Starts: 2014-04-01
Expected to finish: 2016-03-01
Last updated by the study team: 2017-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The subject must meet ALL of the criteria listed below for entry:
Each subject must be willing and able to provide written informed consent for the trial.
Subjects must be willing to adhere to dose and visit schedules.
Each subject must be > 18years of age.
Each subject's weight must be ≥ 40 kg and ≤ 125 kg.
Subject must have previously documented HCV genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the Screening Visit must confirm HCV genotype 1 infection with HCV RNA >10,000 IU/mL. Patients may be either treatment naïve or previously treated as long as they have not been treated with a protease inhibitor. Patients may have compensated cirrhosis.
Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. Each sexually active male subject with a female partner(s) of child-bearing potential must also provide written informed consent to provide information regarding any pregnancy.

You may not qualify if…

The subject will be excluded from entry if ANY of the criteria listed below are met:
Subject is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
Subjects co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (Hepatitis B surface antigen [HBsAg] or HIV positive.
Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary. All herbal remedies including but not limited to St. John's Wort (Hypericum perforatum) used for hepatitis C treatment must be discontinued before Day 1. Only silibinin based products such as silymarin (milk thistle) are allowed during the trial.
Subjects receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations could be associated with serious and/or life-threatening events such as orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine). The following medications are also exclusionary if taken within 2 weeks prior to the Day 1 visit: alfuzosin, cisapride, triazolam, sildenafil, and tadalafil (the latter 2 only if they are used for the indication of chronic obstructive pulmonary disease (COPD).
Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to the subject's medical care).
Evidence of decompensated liver disease.
Subject has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
Subject is diabetic and/or hypertensive with clinically significant ocular examination findings within 6 months prior to the screening visit or between the screening visit and Day 1: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.
Subject has pre-existing psychiatric condition(s) including but not limited to: Current moderate or severe depression or history of severe psychiatric disturbance.
Subject has a clinical diagnosis of substance abuse which the investigators of the following specified drugs within specified timeframes:
Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit, OR
Multi-drug abuse (e.g., two or more of the substances listed in Exclusion Criterion 10a within 3 years of screening visit, OR
Subjects receiving opiate agonist substitution therapy within 1 year of screening visit (except for those subjects monitored in an opioid substitution maintenance program as specified in Section 7.3.5) OR
Subject's historic marijuana use is deemed excessive by a physician investigator or is interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period.
Subject has any known medical condition that could interfere with the subject's participation in and completion of the trial, including, but not limited to:
Central nervous system (CNS) trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or cerebral spinal fluid (CSF) leak. Prior brain hemorrhage and/or intracranial aneurysms (whether adequately repaired or not).
Current uncontrolled seizure disorder unless now controlled on stable medical regimen that does not interact with boceprevir.
History of stroke or transient ischemic attack.
Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder).
Clinically significant chronic pulmonary disease (e.g., clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis).
Current or history of any clinically significant cardiac abnormalities/dysfunction (e.g., angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension, history of use of antianginal agents for cardiac conditions, or clinically significant abnormality on ECG performed at the pre-study screening visit.
Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
Clinically significant gout within the last year.
Clinically significant hemoglobinopathy, including, but not limited to, thalassemia major.

Where it is running

University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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