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Completed

NCT Number: NCT02945228

Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 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

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aichi Medical University Hosp /ID# 161892, 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 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.

Exclusion criteria

  • Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Treatment and study plan

Primary outcomes

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

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

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

Secondary outcomes

  1. Percentage of Participants with Virologic Failure During Treatment (breakthrough)

    Time frame: Up to 12 Weeks

    HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.

  2. Percentage of Participants with Virologic Failure After Treatment (relapse)

    Time frame: Post-treatment 24 weeks

    Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.

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

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

    HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Jun 12, 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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