ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Hepatitis C Virus (HCV) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517515
• Other study ID #: M13-767
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2015
• Last updated: September 29, 2017
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage

• Chronic hepatitis C virus (HCV) infection prior to study enrollment.

• Screening laboratory result indicating HCV subtype 1b (GT1b) infection.

• Per local standard practice, documented absence of cirrhosis.

• Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser

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

Exclusion Criteria:

• HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.

• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.

• Any current or past clinical evidence of cirrhosis.

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

• Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.

• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir and dasabuvir
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
• Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [	12 weeks after the last actual dose of active study drug
Primary	Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)	SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [	24 weeks after the last actual dose of active study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA = LLOQ with at least 6 weeks of active treatment.	up to 12 weeks
Secondary	Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.	From the end of treatment through 12 weeks after the last dose of active study drug
Secondary	Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.	From the end of treatment through 24 weeks after the last dose of active study drug

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