A Study of Viekira/Exviera for Korean Hepatitis C Patients According to the Standard for Re-examination of New Drugs

N/ACompletedNCT03201718

AbbVie505 enrolled

Overview

Post-marketing surveillance study to evaluate the real world safety and effectiveness of Viekira/ Exviera (paritaprevir/ritonavir/ombitasvir and dasabuvir) administered under a normal, routine treatment practice by Korean patients with Hepatitis C.

Study Type

OBSERVATIONAL

Enrollment

505

Conditions

Hepatitis C Virus (HCV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with type C hepatitis * Participants prescribed Viekira/Exviera in accordance with approved local label Exclusion Criteria: * None

Locations (59)

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

the lower limit of quantitation (LLOQ) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.

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

Secondary Outcomes

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase of \> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

Time frame: Up to 24 weeks

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants who complete treatment and with HCV RNA levels \< LLOQ at the end of treatment

Time frame: From the end of treatment through 12 weeks after the last dose of study drug

Data from ClinicalTrials.gov

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Dong-A University Hospital /ID# 167362

Busan, Busan Gwang Yeogsi, South Korea

Pusan National University Hosp /ID# 167363

Busan, Busan Gwang Yeogsi, South Korea

Kyungpook National Univ Hosp /ID# 168731

Daegu, Daegu Gwang Yeogsi, South Korea

Yeungnam University Med Ctr /ID# 167425

Daegu, Daegu Gwang Yeogsi, South Korea

Chungnam National University Hospital /ID# 167724

Junggu, Daejeon Gwang Yeogsi, South Korea

National health insurance cooperation ilsan hospital /ID# 201806

Goyang, Gyeonggido, South Korea

Soon Chun Hyang University Hospital Bucheon /ID# 201803

Habun, Gyeonggido, South Korea

Seoul National Univ Bundang ho /ID# 167394

Seongnam, Gyeonggido, South Korea

St. Vincent's Hospital /ID# 201660

Suwon, Gyeonggido, South Korea

Ajou University Hospital /ID# 167729

Suwon, Gyeonggido, South Korea

...and 49 more locations