Technology-Based Application To Improve The Triple Therapy Adherence Rate In Subjects With Hepatitis C Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02070107|
Recruitment Status : Withdrawn (Sponsored withdrew)
First Posted : February 24, 2014
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Other: On Plan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase 2 Clinical Trial of A Technology-Based Application To Improve The Triple Therapy Adherence Rate In Subjects With Chronic Genotype 1 Hepatitis C Infection|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
no arms, sponsor withdrew
Other: On Plan
"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.
- Treatment Completion [ Time Frame: 24 weeks ]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.
- Virologic response [ Time Frame: 24 weeks ]Virologic response to therapy will be determined at weeks 4, 8, 12, and 24; as well as at the end of treatment (EOTR) and 12 and 24 weeks after treatment completion (SVR12 and SVR24) and compared to historical controls. For these comparisons, subjects will be placed into appropriate subgroups (treatment naïve, relapsers, and non-responders). The percentage of subjects completing the entire course of therapy as initially prescribed will also be compared to historical controls. The percentage of subjects fulfilling the 80/80/80 rule will also be determined and their virologic outcomes determined although direct comparison with historical controls for these endpoints are our institution cannot be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070107
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Matthew Cave, MD||University of Louisville|