A community Observational Program for Hepatitis C treatment
Phase 4
- Conditions
- Health Condition 1: null- Adults infected with viral hepatitis C or being treated forhepatitis C
- Registration Number
- CTRI/2017/01/007644
- Lead Sponsor
- Institute of Human Virology University of Maryland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 325
Inclusion Criteria
Be above 18 years old
2. HCV-infected (naïve/treatment experienced) with HCV RNA >2000 IU/ml
and being evaluated to undergo standard of care treatment,Willing to sign
informed consent
Exclusion Criteria
Unable to comply with research study visits
2. Have any condition that the investigator considers a contraindication to
study participation
3. Pregnancy of breast feeding.
4. CrCL 30 ml/min by CG equation
5. Patients on concurrent amiodarone therapy
6. Currently on medications as per the prohibited concomitant medication
list
7. Decompensated cirrhosis
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the antiviral efficacy of standard of care treatment for HCV in a in resource limited setting. <br/ ><br> <br/ ><br>To determine HCV RNA sensitivity, specificity, and predictive values of the NAAT T8 HCV assay to standard, clinically approved real time PCR assays in a clinical setting <br/ ><br>Timepoint: 12 weeks post treatment <br/ ><br>completion <br/ ><br>
- Secondary Outcome Measures
Name Time Method Determine the HCV treatment cascade: diagnosis, linkage to care, HCV RNA confirmation, prescription of HCV medication, and achieving cure (SVR). <br/ ><br> <br/ ><br> <br/ ><br>Assess the robustness of the T8-Isothermal reagents and equipment. <br/ ><br> <br/ ><br>Determine maintenance and customer support needs. <br/ ><br> <br/ ><br>Determine minimal training needs and user appraisal through a user questionnaire. <br/ ><br> <br/ ><br>Assess the safety of this regimen in a community-based setting. <br/ ><br>Timepoint: 12 Weeks Post Treatment