Clinical Trials Logo
  1. Home
  2. Hepatitis C Virus
  3. NCT01458535
  4. Details
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

— Navigator  

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
See also
  Status Clinical Trial Phase
Completed NCT02907996 - Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02893046 - HCV Care Pathway in Ile-de-France N/A
Completed NCT01396005 - A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) Phase 1
Completed NCT01428063 - Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials Phase 2
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT00219999 - Hepatitis C Virus and the Humoral Immune System N/A
Completed NCT02243293 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection Phase 2/Phase 3
Completed NCT02265237 - A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) Phase 3
Not yet recruiting NCT06104046 - Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
Completed NCT02604017 - A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Phase 3
Withdrawn NCT00947245 - Japanese Bridging Study Conducted in the United States Phase 1
Completed NCT01713283 - Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection Phase 2
Completed NCT01479881 - A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus Phase 1
Completed NCT01241773 - TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir Phase 1
Completed NCT01193361 - Ph IIA Study (SOC +/- NS5B) Phase 2
Completed NCT01006031 - Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4 Phase 2/Phase 3
Completed NCT00819026 - Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors N/A
Completed NCT00382798 - Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin Phase 1/Phase 2
Completed NCT02592057 - Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India