|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02517528 |
|
Date of registration:
|
05/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
|
|
Scientific title:
|
An Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Treatment-Naïve and Treatment-Experienced Asian Adults With GT1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis |
|
Date of first enrolment:
|
July 20, 2015 |
|
Target sample size:
|
104 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02517528 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
China
|
Korea, Republic of
|
Taiwan
| | | | | |
|
Contacts
|
|
Name:
|
AbbVie Inc. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
AbbVie |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and
Taiwanese parentage.
2. Chronic HCV-infection prior to study enrollment.
3. Screening laboratory result indicating HCV genotype 1b-infection.
4. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at
Screening.
5. Per local standard practice, documentation of cirrhosis by one of the following
methods:
- Diagnosis on previous liver biopsy or liver biopsy conducted during screening
e.g., Metavir Score of > 3 (including 3/4 or 3 - 4), Ishak score of > 4 or,
- FibroScan score = 14.6 kiloPascals (kPa) within 6 months of Screening or during
the Screening Period.
Exclusion Criteria:
1. HCV genotype performed during screening indicating unable to genotype or infection
with any other HCV genotype.
2. Positive test result at Screening for Hepatitis B surface antigen (HBsAg), or
hepatitis B virus (HBV) DNA > Lower Limit of Quantification (LLOQ) if HBsAg negative,
or anti-Human Immunodeficiency virus antibody (HIV Ab).
3. Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of
CYP2C8 within 2 weeks or within 10 half-lives, whichever is longer, of the respective
medication/supplement prior to study drug administration.
4. Any current or past clinical evidence of Child-Pugh B or C classification or clinical
history of liver decompensation including ascites (noted on physical exam), variceal
bleeding, or hepatic encephalopathy.
5. Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
6. Confirmed presence of hepatocellular carcinoma (HCC) indicated on imaging techniques
such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3
months prior to Screening or on an ultrasound performed at Screening (a positive
ultrasound result should be confirmed with CT scan or MRI.)
7. Any primary cause of liver disease other than chronic HCV-infection, including but not
limited to the following:
- Hemochromatosis
- Alpha-1 antitrypsin deficiency
- Wilson's disease
- Autoimmune hepatitis
- Alcoholic liver disease
- Drug-related liver disease Steatosis and steatohepatitis on a liver biopsy
coincident with HCV-related changes would not be considered exclusionary unless
the steatohepatitis is considered to be the primary cause of the liver disease.
8. Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic
function.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Hepatitis C Virus (HCV)
|
|
Intervention(s)
|
|
Drug: ABT-333
|
|
Drug: ABT-450/r/ABT-267
|
|
Drug: ribavirin
|
|
Primary Outcome(s)
|
|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)
[Time Frame: 12 weeks after last dose of study drug]
|
|
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
[Time Frame: 24 weeks after last dose of study drug]
|
|
Secondary Outcome(s)
|
|
Percentage of Participants With Virologic Relapse
[Time Frame: Within 12 weeks after the last dose of study drug]
|
|
Percentage of Participants With On Treatment Virologic Failure
[Time Frame: Within 12 weeks after first dose of study drug]
|
|
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24
[Time Frame: Within 24 weeks after the last dose of study drug]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|