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AzTrials

Chronic Hepatitis C InfectionPhase 3PEARL-IINCT01674725

A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and antiviral activity 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) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
ABT-450/r/ABT-267, ABT-333 and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
No sites listed yet
Study dates
Aug 2012to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
  • Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
  • Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

Who cannot join

  • Significant liver disease with any cause other than HCV as the primary cause
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
  • Positive screen for drugs or alcohol
  • Use of contraindicated medications within 2 weeks of dosing

About this study

Official title: 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)

The purpose of this study is to evaluate the safety and antiviral activity 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) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Read the detailed description

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 (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Being tested
ABT-450/r/ABT-267, ABT-333, Ribavirin
Keywords
Hepatitis C virus, Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, Chronic Hepatitis C, Ombitasvir, Ribavirin, Viekira PAK, Dasabuvir, Paritaprevir
Medical subject headings
Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-450/r/ABT-267, ABT-333Drug

    Also called ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, ABT-333 also known as dasabuvir, Viekira PAK

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

  • RibavirinDrug

    Tablet

Study groups in NCT01674725
Study groupRoleWhat they receive
ABT-450/r/ABT-267 and ABT-333, Plus RBVExperimentalABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Receives: Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin
ABT-450/r/ABT-267 and ABT-333ExperimentalABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
Receives: Drug: ABT-450/r/ABT-267, ABT-333

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses

    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. The LLOQ for the assay was 25 IU/mL.

    The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.

    Measured: 12 weeks after last dose of study drug

Secondary outcomes (4)

  1. Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment

    The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.

    Measured: Baseline (Day 1) and Week 12 (End of Treatment)

  2. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses

    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.

    The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.

    Measured: 12 weeks after last dose of study drug

  3. Percentage of Participants With Virologic Failure During Treatment

    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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

    Measured: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

  4. Percentage of Participants With Virologic Relapse After Treatment

    Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.

    Measured: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674725
Sponsor's protocol ID
M13-389
Other IDs
2011-005740-95
Acronym
PEARL-II
Status last verified
Jul 2021
First submitted
27 Jul 2012
Last updated
12 Jul 2021
Data monitoring committee
Yes

Publications

  • Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L Jr, Hu YB, Podsadecki T, Bernstein B. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug;147(2):359-365.e1. doi: 10.1053/j.gastro.2014.04.045. Epub 2014 May 9.

    PubMed 24818763

  • 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.

    PubMed 29377566

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie (prior sponsor, Abbott).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (time frame: 12 weeks after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01674725, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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