Pilot HCV Direct Acting Antiviral Therapy and Metabolism

NCT02734173 | Completed Phase 4 DMC

• 1 other identifier: 20150305-01H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 1.Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.
2. 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. 3.Provide insight into the impact of cirrhosis on metabolic milieu before, during and after HCV antiviral therapy

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin Hepatitis C Antiviral Therapy on Insulin Resistance

  serial insulin sensitivity evaluation

  30 weeks

Secondary Outcomes (1)

• Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin Hepatitis C Antiviral Therapy Lipid Homeostasis

  30 weeks

Study Arms (3)

Genotype 1a Non-Cirrhotic Arm

ACTIVE COMPARATOR

• 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

Genotype 1b Non-Cirrhotic Arm

ACTIVE COMPARATOR

• 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

Genotype 1a/1b Compensated Cirrhotic Arm

ACTIVE COMPARATOR

• 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

Interventions

ABT450r-ABT267-ABT333 +/- Ribavirin DRUG

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

Also known as: ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin

Genotype 1a Non-Cirrhotic Arm; Genotype 1a/1b Compensated Cirrhotic Arm; Genotype 1b Non-Cirrhotic Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• AbbVie: collaborator

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvir; dasabuvir; Ribavirin

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: April 12, 2016
• Study Start: July 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: May 31, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)