A 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)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221298
• Other study ID #: M12-267
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2010
• Last updated: December 29, 2014
• Start date: October 2010
• Est. completion date: April 2012

Study information

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

Clinical Trial Summary

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.

Description:

This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Recruitment information / eligibility

• 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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• HCV
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Genotype 1
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ABT-450
tablets
• ABT-072
tablets
• Ribavirin
tablets
• Ritonavir
capsules

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

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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