A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection

Chronic Hepatitis C Virus Infection Clinical Trial

— Quartz II/III  

Official title:

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292719
• Other study ID #: M14-567
• Secondary ID: 2014-003147-35
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2014
• Est. completion date: July 14, 2017

Study information

• Verified date: July 2021
• 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 efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 14, 2017
• Est. primary completion date: July 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Chronic HCV infection prior to study enrollment.

2. Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).

3. Absence OR presence of cirrhosis.

4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

Exclusion Criteria:

1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody

2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.

3. Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).

4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.

5. Abnormal lab tests.

6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• OBV/PTV/r
Tablet
• Sofosbuvir
Tablet
• Ribavirin (RBV)
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Shafran SD, Shaw D, Charafeddine M, Agarwal K, Foster GR, Abunimeh M, Pilot-Matias T, Pothacamury RK, Fu B, Cohen E, Cohen DE, Gane E. Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III). J Viral Hepat. 2018 Feb;25(2):118-125. doi: 10.1111/jvh.12782. Epub 2017 Sep 14. — View Citation

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 study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA = LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.	Up to Week 12
Secondary	Percentage of Participants With Post-treatment Relapse	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.	Up to 12 weeks after the last actual dose of active study drug