Hepatitis C Clinical Trial
Official title:
An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Verified date | December 2014 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
Status | Completed |
Enrollment | 11 |
Est. completion date | April 2012 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C. - Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV. - Treatment naïve male or female between the ages of 18 and 65. - Females must be postmenopausal for at least 2 years or surgically sterile. - Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection. - Body mass index 18 to < 35 kg/m^2 . Exclusion Criteria: - Significant sensitivity to any drug. - Use of herbal supplements within 2 weeks prior to study drug dosing. - Positive screen for certain drugs or alcohol. - Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) 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. - Prior treatment with any investigational or commercially available anti-hepatitis C virus agents. - Abnormal laboratory tests. - Cirrhosis or extensive bridging fibrosis. - History of cardiac disease. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Site Reference ID/Investigator# 42262 | Chicago | Illinois |
United States | Site Reference ID/Investigator# 41128 | Los Angeles | California |
United States | Site Reference ID/Investigator# 41127 | San Antonio | Texas |
United States | Site Reference ID/Investigator# 43182 | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 | Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). | Week 4 through Week 12 | No |
Secondary | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. | Week 2 | No |
Secondary | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 | Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). | Week 4 | No |
Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. | Post-treatment Day 1 to Post-treatment Week 12 | No |
Secondary | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. | Post-treatment Day 1 to Post-treatment Week 24 | No |
Secondary | Time to Failure to Suppress or Rebound During Treatment | The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA Day 1 through Week 12 |
No |
|
Secondary | Time to Virologic Relapse Through 24 Weeks Post-treatment | Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) = lower limit of quantitation (LLOQ) (2 consecutive measurements = LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. | Post-treatment Day 1 to Post-treatment Week 24 | No |
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