Phase 2 Completed N=50 Treatment

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Chronic Hepatitis C Infection · Hepatitis C

Source: ClinicalTrials.gov NCT01306617 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcomePrimary: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12 — 89.5; 78.6; 58.8 percentage of participants — p=0.547

Summary

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12	89.5; 78.6; 58.8	0.547
SECONDARY Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)	100; 92.9; 100	0.061
SECONDARY Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4	100; 92.9; 88.2	0.061
SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment	94.7; 92.9; 47.1	0.312
SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment	94.7; 85.7; 47.1	0.312
SECONDARY Time to Failure to Suppress or Rebound During Treatment	43.0; NA; 62.6	0.395
SECONDARY Time to Virologic Relapse Post-treatment	NA; NA; 15.8	0.048 sig
SECONDARY Resistance-Associated Variants and Phenotypic Resistance	0; 0; 1; 0; 0; 1	—
SECONDARY Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants	53.21; 16.81; 16.15	—
SECONDARY Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants	148.44; 162.57; 166.15	—
SECONDARY Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants	43.92; 42.35; 44.21	—
SECONDARY Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants	2480; 2280; 2000	—

Eligibility Criteria

Inclusion Criteria

Chronic hepatitis C virus (HCV)
Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
Males and females 18-65 years old
Body mass index 18 to < 35 kg/m^2
Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria

Cirrhosis or extensive bridging fibrosis
History of cardiac disease
Positive screen for certain drugs or alcohol
Abnormal laboratory results
Significant sensitivity to any drug
Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01306617). 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.