Phase 2
Completed N=12
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01563536 ↗
Enrolled (actual)
12
Serious AEs
16.7%
Results posted
Jan 2015
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1 — 1.66; 41.0 ng/mL
Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1 |
1.66; 41.0 | — |
| PRIMARY Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1 |
3.67; 3.67 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1 |
18.0; 467 | — |
| PRIMARY Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3 |
0; 5.2; 0.228; 6.62 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
3; 5; 3; 4; 0; 1 | — |
| PRIMARY Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy |
-1.6; -3.1 | 0.035 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy |
83.3; 83.3; 83.3; 83.3 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response |
83.3; 100 | — |
| SECONDARY Percentage of Participants With End-of-Treatment Response |
83.3; 83.3 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response |
83.3; 83.3 | — |
| SECONDARY Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy |
-1.95; -2.85; -1.96; -3.10 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
- Subject has never received antiviral treatment for hepatitis C virus (HCV) infection.
- Body mass index (BMI) is ≥ 18 to 10,000 IU/mL at screening
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any drug.
- Females who are or plan to become pregnant or breastfeeding or males whose partner is pregnant or planning to become pregnant.
- Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
- Positive test result for hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibodies.
- Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.
Data sourced from ClinicalTrials.gov (NCT01563536). 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.