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Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

An Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

NCT01563536•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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.

Detailed Description

An open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-267 as monotherapy for 2 days, followed by ABT-267, ABT-450 with ritonavir (ABT-450/r) and ABT-333 plus ribavirin (RBV) combination therapy for 12 weeks in treatment-naïve, non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. The study included post-treatment follow-up for 48 weeks.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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 \< 38 kg/m\^2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
•Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
•Subject has plasma HCV RNA level \> 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.

Locations (4)

Site Reference ID/Investigator# 68002

Bakersfield, California, United States

Site Reference ID/Investigator# 67383

Orlando, Florida, United States

Site Reference ID/Investigator# 67382

Annapolis, Maryland, United States

Site Reference ID/Investigator# 67385

Poughkeepsie, New York, United States

Key Dates

Start Date

February 1, 2012

Primary Completion Date

April 1, 2012

Completion Date

June 1, 2013

Last Updated

July 2, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C Infection

Interventions

ABT-267

DRUG

ABT-450

DRUG

ABT-333

DRUG

Ritonavir

DRUG

Ribavirin

DRUG

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

NCT01866930

Chronic Hepatitis C Infection

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COMPLETED

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

NCT02333292

Chronic Hepatitis C Infection

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COMPLETEDPHASE3

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection