Phase 3
Completed N=104
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
Chronic Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT02517528 ↗
Enrolled (actual)
104
Serious AEs
3.9%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) — 100 percentage of participants
◆ Published Evidence
Emerging
2citations · ~0 / year
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Summary
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.
Linked Publications
-
Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir in Healthy Chinese Subjects and HCV GT1b-Infected Chinese, South Korean and Taiwanese Patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) |
100 | — |
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) |
100 | — |
| SECONDARY Percentage of Participants With On Treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Virologic Relapse |
— | — |
| SECONDARY Percentage of Participants With Virologic Relapse by Post-Treatment Week 24 |
— | — |
Eligibility Criteria
Inclusion Criteria
- Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage.
- Chronic HCV-infection prior to study enrollment.
- Screening laboratory result indicating HCV genotype 1b-infection.
- Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening.
- 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
- HCV genotype performed during screening indicating unable to genotype or infection with any other HCV genotype.
- 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).
- 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.
- 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.
- Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
- 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.)
- 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.
- Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
Data sourced from ClinicalTrials.gov (NCT02517528) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.