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A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis (TURQUOISE-II)

Primary Purpose

Chronic Hepatitis C Infection, Compensated Cirrhosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ABT-450/r/ABT-267, ABT-333

Ribavirin (RBV)

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Cirrhosis, Hepatitis C, Child Pugh A, Compensated Cirrhosis, Hepatitis C Genotype 1, Cirrhotic, Chronic Hepatitis C, Hepatitis C Virus, ombitasvir, paritaprevir, dasabuvir, Interferon-Free, Viekira Pak

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
Male or female between 18 and 70 years, inclusive, at time of Screening.
Chronic HCV-infection prior to study enrollment.
Screening laboratory result indicating HCV genotype 1-infection.
Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

Significant liver disease with any cause other than HCV as the primary cause
Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

Arm Description

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm

A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.

Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

Percentage of Participants With Virologic Relapse After Treatment

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

Full Information

NCT ID

NCT01704755

First Posted

September 28, 2012

Last Updated

July 8, 2021

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01704755

Brief Title

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

Acronym

TURQUOISE-II

Official Title

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed Description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Infection, Compensated Cirrhosis

Keywords

Cirrhosis, Hepatitis C, Child Pugh A, Compensated Cirrhosis, Hepatitis C Genotype 1, Cirrhotic, Chronic Hepatitis C, Hepatitis C Virus, ombitasvir, paritaprevir, dasabuvir, Interferon-Free, Viekira Pak

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

381 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks

Arm Type

Experimental

Arm Description

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks

Arm Title

ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks

Arm Type

Experimental

Arm Description

ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks

Intervention Type

Drug

Intervention Name(s)

ABT-450/r/ABT-267, ABT-333

Other Intervention Name(s)

Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir

Intervention Description

Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet

Intervention Type

Drug

Intervention Name(s)

Ribavirin (RBV)

Intervention Description

Capsule

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment

Description

Time Frame

12 weeks after the last actual dose of study drug

Secondary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm

Description

A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.

Time Frame

12 weeks after the last actual dose of study drug

Title

Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period

Description

Time Frame

Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

Title

Percentage of Participants With Virologic Relapse After Treatment

Description

Time Frame

within 12 weeks after the last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile Male or female between 18 and 70 years, inclusive, at time of Screening. Chronic HCV-infection prior to study enrollment. Screening laboratory result indicating HCV genotype 1-infection. Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening. Exclusion Criteria: Significant liver disease with any cause other than HCV as the primary cause Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening. Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir. Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy. A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger Trinh, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

24725237

Citation

Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.

Results Reference

background

PubMed Identifier

29377566

Citation

Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.

Results Reference

derived

PubMed Identifier

26248955

Citation

Forns X, Poordad F, Pedrosa M, Berenguer M, Wedemeyer H, Ferenci P, Shiffman ML, Fried MW, Lovell S, Trinh R, Lopez-Talavera JC, Everson G. Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia. Liver Int. 2015 Nov;35(11):2358-62. doi: 10.1111/liv.12931. Epub 2015 Sep 6.

Results Reference

derived

Links:

URL

http://rxabbvie.com

Description

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