An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Sponsors

Lead sponsor: AbbVie

Source AbbVie
Brief Summary

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Detailed Description

This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Overall Status Completed
Start Date September 2014
Completion Date September 2015
Primary Completion Date June 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment Post-treatment Day 1 to Post-treatment Week 12
Secondary Outcome
Measure Time Frame
Percentage of Participants With On-Treatment Virologic Failure Day 1 through Week 12
Percentage of Participants With Post-Treatment Relapse Post-treatment Day 1 to Post-treatment Week 12
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: Ombitasvir/Paritaprevir/Ritonavir

Description: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Intervention type: Drug

Intervention name: Dasabuvir

Description: Tablet

Arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Other name: ABT-333

Eligibility

Criteria:

Inclusion Criteria:

1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:

- Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or

- HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).

2. Screening laboratory result indicating HCV genotype 1b-infection.

3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).

3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)

5. Use of contraindicated medications within 2 weeks of dosing

6. Screening laboratory analyses showing any of the following abnormal laboratory results:

- Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min

- Albumin < 2.8 g/dL

- International normalized ratio (INR) > 1.8. Participants with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.

- Hemoglobin < 10 g/dL

- Platelets < 25,000 cells per mm3

- Total bilirubin > 3.0 mg/dL

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Roger Trinh, MD Study Director AbbVie
Verification Date

May 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

Arm group type: Experimental

Description: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks

Acronym TURQUOISE-III
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov