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Pilot HCV Direct Acting Antiviral Therapy and Metabolism (3D)

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: NCT02734173
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: ABT450r-ABT267-ABT333 +/- Ribavirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin HCV Therapy on Insulin Resistance and Lipid Profile
Actual Study Start Date : July 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Genotype 1a Non-Cirrhotic Arm
• 8 non-cirrhotic genotype 1a-infected recipients will receive a 12 week course of ABT450r-ABT267-ABT333 therapy plus ribavirin
Drug: ABT450r-ABT267-ABT333 +/- Ribavirin
12 week duration of HCV antiviral therapy with ABT450r-ABT267-ABT333 +/- Ribavirin
Other Name: ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin

Active Comparator: Genotype 1b Non-Cirrhotic Arm
• 8 non-cirrhotic genotype 1b-infected recipients will receive a 12 week course of ABT450r-ABT267-ABT333 therapy without ribavirin
Drug: ABT450r-ABT267-ABT333 +/- Ribavirin
12 week duration of HCV antiviral therapy with ABT450r-ABT267-ABT333 +/- Ribavirin
Other Name: ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin

Active Comparator: Genotype 1a/1b Compensated Cirrhotic Arm
• 8 compensated cirrhotic genotype 1a or 1b-infected recipients will receive a 12 week course of ABT450r-ABT267-ABT333 therapy plus ribavirin
Drug: ABT450r-ABT267-ABT333 +/- Ribavirin
12 week duration of HCV antiviral therapy with ABT450r-ABT267-ABT333 +/- Ribavirin
Other Name: ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin




Primary Outcome Measures :
  1. Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin Hepatitis C Antiviral Therapy on Insulin Resistance [ Time Frame: 30 weeks ]
    serial insulin sensitivity evaluation


Secondary Outcome Measures :
  1. Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin Hepatitis C Antiviral Therapy Lipid Homeostasis [ Time Frame: 30 weeks ]
    serial lipid homeostasis evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV RNA evidence of HCV infection
  • Documented history of chronic HCV RNA infection with Genotype 1
  • Able to provide informed consent
  • Available for ongoing follow-up if required

Exclusion Criteria:

  • <18 years old
  • Evidence of decompensated liver disease
  • HOMA IR< 2.0
  • HIV seropositivity
  • Chronic HBV/HIV infection
  • Use of immune suppressing medications
  • Active malignancy

Information from the National Library of Medicine

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): NCT02734173


Locations
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Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
AbbVie

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02734173    
Other Study ID Numbers: 20150305-01H
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication Conference presentation Knowledge translation with community groups
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents