A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection

Chronic Hepatitis C Clinical Trial

Official title:

An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-530, With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 3 Chronic Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068222
• Other study ID #: M14-213
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2014
• Last updated: January 25, 2018
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Description:

Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index =18 to <38 kg/m2.

• Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.

• Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.

• Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any drug.

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).

• Prior therapy for the treatment of HCV.

• Any current or past clinical evidence of cirrhosis.

• Any cause of liver disease other than chronic HCV-infection.

• HCV genotype co-infection with any other HCV genotype.

• Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ABT-450/ritonavir (r)
Tablet
• ABT-530
Tablet
• Ribavirin (RBV)
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):112 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)	SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.	12 weeks after last dose of study drug
Secondary	The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)	SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.	24 weeks after last dose of study drug
Secondary	The Percentage of Subjects With Virologic Failure During Treatment	Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.	Up to Treatment Week 12
Secondary	The Percentage of Subjects With Post-Treatment Relapse	Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.	Within 12 weeks after the last dose of study drug