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Pilot HCV Direct Acting Antiviral Therapy and Metabolism

NCT02734173 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-08-13

No results posted yet for this study

Summary

There is compelling data supporting the pursuit of research into the effects of HCV antivirals on metabolic homeostasis. As a further rationale and justification, the experience with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce profound changes in glucose metabolism, lipid profile and other measures of metabolic homeostasis. This establishes biological plausibility for this focus of research in HCV.

The new knowledge created from this research will:

1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.
2. Provide insight as to whether there are metabolic advantages with RBV-free compared to RBV-containing HCV regimens. This is particularly relevant given the current uncertainty regarding the need for RBV in IFN-free, oral DAA regimens.
3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and after HCV antiviral therapy

Conditions

  • Hepatitis C

Interventions

DRUG

ABT450r-ABT267-ABT333 +/- Ribavirin

12 week duration of HCV antiviral therapy with ABT450r-ABT267-ABT333 +/- Ribavirin

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-02-28
Completion
2017-05-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734173 on ClinicalTrials.gov