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Hepatitis C VirusPhase 2NavigatorNCT01458535

A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

A Phase 2 study testing ABT-450, ABT-267 and ribavirin in people with Hepatitis C Virus, 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 was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C Virus
What is being tested?
ABT-450, ABT-267 and ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
No sites listed yet
Study dates
Sep 2011to May 2013
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who had a body mass index 18 to < 35 kg/m^2.
  • Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
  • Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
  • Participants were in a condition of general good health, other than the HCV infection.
  • Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

Who cannot join

  • Positive drug screen
  • Previous use of anti-HCV agents
  • History of cardiac disease
  • History of uncontrolled diabetes or diabetes requiring insulin
  • Abnormal laboratory results
  • Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
  • Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.

About this study

Official title: An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.

Read the detailed description

This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

Being tested
ABT-450, ABT-267, ribavirin, ritonavir
Keywords
Genotype 1, Genotype 2, Genotype 3, Hepatitis C Virus, ABT-450/r, Ribavirin, ABT-267, Ombitasvir, Paritaprevir
Medical subject headings
Hepatitis C

What participants receive

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

  • ABT-450Drug

    Also called paritaprevir

    tablets

  • ABT-267Drug

    Also called ombitasvir

    tablets

  • ribavirinDrug

    tablets

  • ritonavirDrug

    Also called Norvir

    capsules

Study groups in NCT01458535
Study groupRoleWhat they receive
ABT-450/r and ABT-267 plus RBV in genotype 1 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ribavirin; Drug: ritonavir
ABT-450/r and ABT-267 plus RBV in genotype 2 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ribavirin; Drug: ritonavir
ABT-450/r and ABT-267 plus RBV in genotype 3 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ribavirin; Drug: ritonavir
ABT-450/r and ABT-267 in genotype 1 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ritonavir
ABT-450/r and ABT-267 in genotype 2 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ritonavir
ABT-450/r and ABT-267 in genotype 3 participantsExperimentalABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
Receives: Drug: ABT-450; Drug: ABT-267; Drug: ritonavir

What is being measured

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

  1. Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]

    Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.

    Measured: Week 4 through Week 12

Secondary outcomes (6)

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment

    Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.

    Measured: Post-treatment Day 1 to Post-treatment Week 12

  2. Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment

    Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.

    Measured: Post-treatment Day 1 to Post-treatment Week 24

  3. Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)

    Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.

    Measured: Week 2

  4. Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)

    Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.

    Measured: Week 4

  5. Percentage of Participants With Virologic Failure During Treatment

    Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).

    Measured: Day 1 through Week 12

  6. Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)

    Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.

    Measured: Post-treatment Day 1 to Post-treatment Week 48

Timeline

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

  1. First posted25 Oct 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01458535
Sponsor's protocol ID
M12-998
Acronym
Navigator
Status last verified
May 2016
First submitted
23 Sep 2011
Last updated
11 Jul 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-450, ABT-267 and ribavirin in people with Hepatitis C Virus, 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 5 inclusion and 7 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 11 Jul 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Jul 2016). 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 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] (time frame: Week 4 through Week 12). 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 NCT01458535.

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 11 Jul 2016.

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