Clinical Trials List
2015-10-20 - 2017-05-30
Phase III
Terminated4
Study ended1
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, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)
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Trial Applicant
AbbVie
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Sponsor
Abbvie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳介章 Digestive System Department
- Chen-Hua Liu 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
9 Terminated
Audit
None
Co-Principal Investigator
- 呂宜達 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Lun Yeh Digestive System Department
- Jee-Fu Huang Digestive System Department
- Ming-Lung Yu Digestive System Department
- Wan-Long Chuang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Shih-Jer Hsu 未分科
Audit
None
Co-Principal Investigator
- Hung-Yao Chen Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 陳昇弘 Digestive System Department
- 蘇文邦 Digestive System Department
The Actual Total Number of Participants Enrolled
10 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
< LLOQ 12 weeks after the last actual dose of study drug) for the subjects treated with
ABT-493/ABT-530 in the Double-Blind Treatment Period (Arm A), excluding prior SOF
+ RBV ± pegIFN failures. The percentage of these subjects treated with
ABT-493/ABT-530 with SVR12 will be non-inferior to the 95% SVR12 rate of the current
standard of care (sofosbuvir + RBV for 12 weeks) if the LCB of the 2-sided 95%
confidence interval of the percentage of subjects with SVR12 is > 89%.
The normal approximation to the binomial distribution will be used to calculate the
confidence intervals unless the rate for the primary endpoint is 100%, then the Wilson's
score method will be used for the confidence intervals instead.
In order to control the Type I error rate, a fixed sequence testing procedure will be used
for the primary efficacy endpoint and the first secondary efficacy endpoint. Only if
success has been demonstrated for the primary endpoint (non-inferiority of the SVR12 rate of Arm A to the historical control rate) will the testing proceed to the first
secondary endpoint (superiority of the SVR12 rate in Arm A to the historical control rate).
Inclution Criteria
2. Screening laboratory result indicating HCV GT2 infection.
3. Chronic HCV infection.
4. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved
or investigational regimen) or has failed prior IFN or pegIFN with or without RBV, or SOF plus
RBV with or without PegIFN therapy. Prior HCV treatment with any other approved or
investigational medications is not allowed.
5. Subjects must be non-cirrhotic.
Exclusion Criteria
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
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Taiwan
64 participants
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Global
291 participants
