Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks (3D8)

May 18, 2018 updated by: Hepa C

Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Carrion, Jose Antonio, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with HCV who are treated in real practice with Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir

Description

Inclusion Criteria:

  • Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
  • Genotype 1b infection
  • Treatment-naïve and non-cirrhotic

Exclusion Criteria:

  • HCV genotype or subtype other than GT1b.
  • Any current or past clinical evidence of cirrhosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spanish cohort with HCV treated with DAA
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks
Drug: ombitasvir/paritaprevir/ritonavir 8 weeks
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
Other Names:
  • viekirax
Drug: dasabuvir 8 weeks
Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks
Other Names:
  • exviera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response 12 weeks post-treatment (SVR12)
Time Frame: 12 weeks after the last dose of study drug

Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12)

• Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
12 weeks after the last dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with virologic failure during treatment
Time Frame: Up to 12 weeks after last dose of study drug

Percentage of patients with virologic failure during treatment

• Measure: Percentage of patients with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment
Up to 12 weeks after last dose of study drug
Mild fibrosis and sustained virological response 12 weeks post-treatment
Time Frame: Up to 12 weeks after last dose of study drug

Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment

• Measure: percentage of patients with a baseline transient elastography < 6 kPa
Up to 12 weeks after last dose of study drug
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment
Time Frame: Baseline and 12 weeks after the last dose of drug

Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment

• Measure: HCV RNA levels less than the lower limit of quantification.
Baseline and 12 weeks after the last dose of drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepa C

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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