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Completed

NCT Number: NCT02581020

The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

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Key information

Conditions

Hepatitis C Virus 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–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya City University Hospital /ID# 157439, Nagoya, 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

  • Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
  • Participants who agree to sign the informed consent

Exclusion criteria

  • Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

Treatment and study plan

Primary outcomes

  1. Hepatitis C virus ribonucleic acid (HCV RNA) levels

    Time frame: 60 months after completion of the 2D treatment in M12-536 or M13-004 study

    HCV RNA levels in plasma

Secondary outcomes

  1. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)

    Time frame: For approximately 5 years

  2. Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)

    Time frame: For approximately 5 years

  3. Percentage of participants with hepatocellular carcinoma

    Time frame: Up to 60 month after completion of the 2D treatment in M12-536 or M13-004

  4. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study

    All serious adverse events will be monitored during the observation period.

  5. Hepatitis C virus ribonucleic acid (HCV RNA) levels

    Time frame: 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study

    HCV RNA levels in plasma

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2015
Registry last updated
Dec 8, 2021

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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