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Completed

NCT Number: NCT03122132

Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

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).

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carrion, Jose Antonio, PhD

Barcelona, 08003, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ombitasvir/paritaprevir/ritonavir 8 weeks

Drug

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks

Other names: viekirax

dasabuvir 8 weeks

Drug

Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks

Other names: exviera

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Hepa C

Other

Registry information

Official study title

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.

Acronym: 3D8

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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