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Completed

NCT Number: NCT02629172

Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

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Key information

Conditions

Chronic Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Medical University Hosp /ID# 152220, Nagakute, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice

Exclusion criteria

  • Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir

Treatment and study plan

Primary outcomes

  1. Percentage of Participants with Sustained Virologic Response (SVR12)

    Time frame: 12 weeks after the last dose of study drug

    Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.

Secondary outcomes

  1. Percentage of Participants with Virologic Failure After Treatment

    Time frame: Post-treatment 24 weeks

    Confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) at the end of 12 week treatment but subsequent viremia with HCV RNA greater than or equal to the lower limit of quantitation during follow-up period of 24 weeks after treatment.

  2. Percentage of Participants with Sustained Virologic Response (SVR24)

    Time frame: 24 weeks after the last dose of study drug

    Hepatitis C virus ribonucleic acid less than the lower limit of quantification 24 weeks after the last dose of study drug.

  3. Percentage of Participants with Virologic Failure During Treatment

    Time frame: Up to Week 12

    HCV RNA levels reach less than the lower limit of quantitation (LLOQ), then increase to greater than or equal to the LLOQ at any point during treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2015
Registry last updated
Feb 24, 2020

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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