A study to evaluate the safety and effect of three experimental drugs ABT-450, ABT-267, and ABT-333 in people with HCV. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.

A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL–II)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005740-95-SE

Enrollment

210

Registered

2012-07-19

Start date

2012-08-22

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection MedDRA version: 15.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: ABT-450/ritonavir/ABT-267 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ABT-450 Current Sponsor code: ABT-450 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female and is between 18 and 70 years, inclusive, at time of screening. 2. Subject failed previous treatment with pegIFN and RBV 3. Chronic HCV genotype 1b-infection for at least 6 months prior to study Screening 4. Subject's HCV genotype is subgenotype 1b at Screening without co-infection with any other genotype/subgenotype. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Recent history of drug or alcohol abuse 2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-HIV antibodies (anti-HIV Ab). 3. Any current or past clinical evidence of cirrhosis 4. Any cause of liver disease other than chronic HCV infection.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study are to evaluate the safety of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV, and to show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks following therapy]) of both arms to the historical SVR rate of telaprevir plus pegIFN and RBV.;Secondary Objective: The secondary objectives of this study are: - To compare the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) by the end of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV and without RBV; - To show the superiority in SVR12 rates of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV to the historical SVR rate of telaprevir plus pegIFN and RBV therapy; - To show the non-inferiority in SVR12 rates of 12 weeks of treatment with ABT-450/r/ABT-267, and ABT-333 without RBV (3 DAA/12) to 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV (3 DAA/RBV/12); - To summarize the percentage of subjects with virologic failure during treatment and the percentage of subjects with relapse post-treatment in each of the treatment groups.;Primary end point(s): The primary efficacy endpoints are: (1) SVR12: non inferiority of Arm 2 to the historical rate for telaprevir plus pegIFN/RBV. (2) SVR12: non inferiority of Arm 1 to the historical rate for telaprevir plus pegIFN/RBV ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs	—

Measure

Time frame

Main Objective: The primary objectives of this study are to evaluate the safety of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV, and to show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week sustained virologic response, SVR12, [HCV RNA < LLOQ 12 weeks following therapy]) of both arms to the historical SVR rate of telaprevir plus pegIFN and RBV.;Secondary Objective: The secondary objectives of this study are: - To compare the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) by the end of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV and without RBV; - To show the superiority in SVR12 rates of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with and without RBV to the historical SVR rate of telaprevir plus pegIFN and RBV therapy; - To show the non-inferiority in SVR12 rates of 12 weeks of treatment with ABT-450/r/ABT-267, and ABT-333 without RBV (3 DAA/12) to 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV (3 DAA/RBV/12); - To summarize the percentage of subjects with virologic failure during treatment and the percentage of subjects with relapse post-treatment in each of the treatment groups.;Primary end point(s): The primary efficacy endpoints are: (1) SVR12: non inferiority of Arm 2 to the historical rate for telaprevir plus pegIFN/RBV. (2) SVR12: non inferiority of Arm 1 to the historical rate for telaprevir plus pegIFN/RBV ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints included in the fixed-sequence are: (3) Comparison of the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) at the end of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV versus without RBV. (4) SVR12: Superiority of Arm 1 to the historical rate for telaprevir plus pegIFN/RBV (5) SVR12: Superiority of Arm 2 to the historical rate for telaprevir plus pegIFN/RBV (6) SVR12: Non-inferiority of Arm 2 to Arm 1. Other secondary endpoints not included in the fixed sequence are: ? The percentage of subjects in each treatment group with virologic failure during treatment (defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment or confirmed HCV RNA = LLOQ at the end of treatment), and ? The percentage of subjects in each treatment group with post-treatment relapse (defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drugs among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment). ;Timepoint(s) of evaluation of this end point: During treatment or at the end of treatment (last dose of study drug)	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints included in the fixed-sequence are: (3) Comparison of the percentage of subjects with a decrease in hemoglobin to below the lower limit of normal (LLN) at the end of treatment with ABT-450/r/ABT-267 and ABT-333 with RBV versus without RBV. (4) SVR12: Superiority of Arm 1 to the historical rate for telaprevir plus pegIFN/RBV (5) SVR12: Superiority of Arm 2 to the historical rate for telaprevir plus pegIFN/RBV (6) SVR12: Non-inferiority of Arm 2 to Arm 1. Other secondary endpoints not included in the fixed sequence are: ? The percentage of subjects in each treatment group with virologic failure during treatment (defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment or confirmed HCV RNA = LLOQ at the end of treatment), and ? The percentage of subjects in each treatment group with post-treatment relapse (defined as confirmed HCV RNA = LLOQ between end of treatment and 12 weeks after the last dose of study drugs among subjects completing treatment and with HCV RNA < LLOQ at the end of treatment). ;Timepoint(s) of evaluation of this end point: During treatment or at the end of treatment (last dose of study drug)

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Countries

Austria, Belgium, Italy, Netherlands, Portugal, Puerto Rico, Sweden, Switzerland, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

euclinicaltrials@abbott.com+44162877 4695

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026