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OpenTrials
Completed

NCT Number: NCT03071133

Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Completed

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Tokyo, 1620814, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration

Exclusion criteria

  • Patients who use the DCV Trio off label

Treatment and study plan

Primary outcomes

  1. Incidence of Aspartate Aminotransferase (AST) elevation

    Time frame: Up to 36 weeks

    measured by immunoassay

  2. Incidence of Alanine Aminotransferase (ALT) elevation

    Time frame: Up to 36 weeks

    measured by immunoassay

  3. Incidence of Total Bilirubin (tBili) elevation

    Time frame: Up to 36 weeks

    measured by immunoassay

Secondary outcomes

  1. Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan

    Time frame: Up to 36 weeks

    measured by adverse events

  2. Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)

    Time frame: Up to 24 weeks

    measured by number of patients

  3. Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)

    Time frame: Up to 36 weeks

    measured by number of patients

  4. Percentage of patients to experience virologic breakthrough

    Time frame: Up to 36 weeks

    measured by percentage of patients

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2017
Registry last updated
Feb 23, 2022

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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