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

Completed

• Conditions: Hepatitis C Virus (HCV)

• Registration Number: NCT03201718
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Study Start: 2017-08-17
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• Participants with type C hepatitis
• Participants prescribed Viekira/Exviera in accordance with approved local label

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)	12 weeks after the last dose of study drug	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Post-treatment Relapse	From the end of treatment through 12 weeks after the last dose of study drug	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
Percentage of Participants With On-treatment Virologic Failure	Up to 24 weeks	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.

Trial Locations

Locations (59)

Dong-A University Hospital /ID# 167362; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Pusan National University Hosp /ID# 167363; 🇰🇷 Busan, Busan Gwang Yeogsi, Korea, Republic of

Kyungpook National Univ Hosp /ID# 168731; 🇰🇷 Daegu, Daegu Gwang Yeogsi, Korea, Republic of

Yeungnam University Med Ctr /ID# 167425; 🇰🇷 Daegu, Daegu Gwang Yeogsi, Korea, Republic of

Chungnam National University Hospital /ID# 167724; 🇰🇷 Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon /ID# 201803; 🇰🇷 Buncheon, Gyeonggido, Korea, Republic of

National health insurance cooperation ilsan hospital /ID# 201806; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of

Seoul National Univ Bundang ho /ID# 167394; 🇰🇷 Seongnam, Gyeonggido, Korea, Republic of

Ajou University Hospital /ID# 167729; 🇰🇷 Suwon-si, Gyeonggido, Korea, Republic of

St. Vincent's Hospital /ID# 201660; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of

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