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NCT01458535 Clinical Trial

A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

Hepatitis C Virus Clinical Trial

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Official title:
An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01458535
Other study ID # M12-998
Secondary ID
Status Completed
Phase Phase 2
First received September 23, 2011
Last updated May 30, 2014
Start date October 2011
Est. completion date May 2013

Study information
Verified date May 2014
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) when given together with ABT-267 and with and without Ribavirin (RBV) in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Chronic Hepatitis C Virus (Genotype 1, 2 or 3)

- Male or female 18-65 years old, inclusive

Exclusion Criteria:

- Positive drug screen

- Previous use of anti-HCV agents

- History of cardiac disease

- History of uncontrolled diabetes or diabetes requiring insulin

- Abnormal laboratory results

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-450/r
tablet (ABT-450), capsule (ritonavir)
• ABT-267
tablet
• ribavirin
tablet

Locations
Country Name City State
Puerto Rico Site Reference ID/Investigator# 60982 San Juan
United States Site Reference ID/Investigator# 61001 Annandale Virginia
United States Site Reference ID/Investigator# 60991 Aurora Colorado
United States Site Reference ID/Investigator# 61005 Birmingham Alabama
United States Site Reference ID/Investigator# 60994 Bradenton Florida
United States Site Reference ID/Investigator# 61007 Cincinnati Ohio
United States Site Reference ID/Investigator# 60995 Dothan Alabama
United States Site Reference ID/Investigator# 60992 Kansas City Missouri
United States Site Reference ID/Investigator# 62762 Los Angeles California
United States Site Reference ID/Investigator# 61002 Marietta Georgia
United States Site Reference ID/Investigator# 60999 San Antonio Texas
United States Site Reference ID/Investigator# 60987 San Diego California
United States Site Reference ID/Investigator# 60997 Seattle Washington
United States Site Reference ID/Investigator# 60984 Shreveport Louisiana
United States Site Reference ID/Investigator# 60985 St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the safety and antiviral activity (proportion of subjects with hepatitis C ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) Week 4 and Week 12 (eRVR) No
Secondary Assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 Weeks post-treatment) Post-Treatment Week 12 No
Secondary Assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 Weeks post-treatment) Post-Treatment Week 24 No
Secondary Assess the percentage of subjects with HCV RNA < 1000 IU/mL Week 2 No
Secondary Assess the percentage of subjects with HCV RNA < LLOQ Week 4 No
Secondary Assess the time to failure to suppress, rebound or relapse (confirmed increase of at least 1 log10 IU/mL above nadir or confirmed HCV RNA > LLOQ for subjects who previously achieved HCV RNA < LLOQ) Day 1 to Post Treatment Week 24 No
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