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

NCT02070107 | Withdrawn

• 1 other identifier: OICN130565
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Treatment Completion

  The percentage of patients completing treatment weeks 4, 8, 12, and 24 will be compared to historical controls treated with boceprevir-based triple therapy from our institution. In subjects not completing therapy as prescribed the reasons for discontinuation will be characterized including non-adherence and side effects and also compared to the historical controls.

  24 weeks

Secondary Outcomes (1)

• Virologic response

  24 weeks

Study Arms (1)

no arms

OTHER

no arms, sponsor withdrew

Other: On Plan

Interventions

On Plan OTHER

"On Plan" is a highly customizable software package developed by our co-investigator at the University of Louisville for a variety of applications related to compliance.

no arms

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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
• 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.

Sponsors & Collaborators

• University of Louisville: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Matthew Cave, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 24, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

US (1)