Clinical Trials List
2015-10-26 - 2017-05-30
Phase III
Terminated8
ICD-10B18.2
Chronic viral hepatitis C
ICD-10B18
Chronic viral hepatitis
ICD-9070.54
Chronic hepatitis C without mention of hepatic coma
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 1 Infection (ENDURANCE-1)
-
Trial Applicant
AbbVie
-
Sponsor
AbbVie
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 蘇文邦 Digestive System Department
- 陳昇弘 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- Hung-Yao Chen Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chen-Hua Liu Digestive System Department
- 陳介章 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 林崇棋 Digestive System Department
The Actual Total Number of Participants Enrolled
5 Terminated
Audit
None
Co-Principal Investigator
- 呂宜達 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- Ming-Lung Yu Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 蘇東弘 Digestive System Department
- Chen-Hua Liu Digestive System Department
- PEI-JER CHEN Digestive System Department
- Shih-Jer Hsu 未分科
- Chun-Jen Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Plasma HCV RNA (IU/mL) will be assessed at each Treatment and Post-Treatment Visit.
Safety:
Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical
laboratory tests, 12-Lead ECGs, and vital signs.
Patient Reported Outcomes (PROs):
Health state utility will be measured using the EuroQol-5 Dimensions-3 Level (EQ-5D-3L) instrument.
Resistance:
The following information will be tabulated and summarized: 1) for all subjects, the variants at baseline
at signature resistance-associated amino acid positions relative to the appropriate prototypic reference
sequence; and 2) for subjects who do not achieve SVR12, post-baseline variants relative to baseline.
Pharmacokinetic:
Individual plasma concentrations of ABT-493 and ABT-530, and possible metabolites of ABT-493 and
ABT-530 will be tabulated and summarized.
Inclution Criteria
1. Male or female, at least 18 years of age at time of screening.
2. Screening laboratory result indicating HCV GT1 infection.
3. Chronic HCV infection.
4. Subject must be HCV DAA treatment-naïve.
5. Subjects must be non-cirrhotic.
Exclusion Criteria
1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male
whose partner is pregnant or planning to become pregnant during the study.
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that
could preclude adherence to the protocol in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human
immunodeficiency virus antibody (HIV Ab).
5. HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.
The Estimated Number of Participants
-
Taiwan
64 participants
-
Global
620 participants
