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

NCT ID: NCT02219503

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Chronic Hepatitis C Infection; Compensated Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir

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

Group Type: EXPERIMENTAL

Ombitasvir/Paritaprevir/Ritonavir

Intervention Type: DRUG

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Dasabuvir

Intervention Type: DRUG

Tablet

Interventions

Ombitasvir/Paritaprevir/Ritonavir

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Intervention Type: DRUG

Dasabuvir

Tablet

Intervention Type: DRUG

Other Intervention Names

ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; Ritonavir also known as norvir; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Trinh, MD

Role: STUDY_DIRECTOR

AbbVie

References

Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.

Reference Type: BACKGROUND

PMID: 26476290 (View on PubMed)

Related Links

http://www.rxabbvie.com/

Related Info

Other Identifiers

2014-001953-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-490

Identifier Type: -

Identifier Source: org_study_id