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Completed

NCT Number: NCT02727933

Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

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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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
  • Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

Exclusion criteria

  • Off-label use of Daklinza and Sunvepra
  • Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

Treatment and study plan

Primary outcomes

  1. Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities

    Time frame: 6 months to 5 years

Secondary outcomes

  1. Incidence proportion of AEs leading to discontinuation of study therapy

    Time frame: 6 months to 5 years

  2. Incidence rate of AEs leading to discontinuation of study therapy

    Time frame: 6 months to 5 years

  3. Timing of laboratory abnormalities by toxicity grade

    Time frame: 6 months to 5 years

  4. Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected

    Time frame: 4 Weeks to 24 Weeks

  5. The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)

    Time frame: 24 Weeks to 36 Weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2016
Registry last updated
Jan 21, 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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