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Hepatitis CPhase 2NCT01221298

A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)

A Phase 2 study testing ABT-450, ABT-072 and Ribavirin in people with Hepatitis C and HCV, run by AbbVie (prior sponsor, Abbott) at 4 sites in United States.

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, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, HCV, Chronic Hepatitis C Infection
What is being tested?
ABT-450, ABT-072 and Ribavirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesUnited States
Study dates
Oct 2010to Apr 2012
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

  • Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
  • Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
  • Treatment naïve male or female between the ages of 18 and 65.
  • Females must be postmenopausal for at least 2 years or surgically sterile.
  • Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
  • Body mass index 18 to < 35 kg/m^2 .

Who cannot join

  • Significant sensitivity to any drug.
  • Use of herbal supplements within 2 weeks prior to study drug dosing.
  • Positive screen for certain drugs or alcohol.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
  • Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
  • Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
Show all 9Show fewer
  • Abnormal laboratory tests.
  • Cirrhosis or extensive bridging fibrosis.
  • History of cardiac disease.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Site Reference ID/Investigator# 42262

    Chicago, Illinois, 60637

  • Site Reference ID/Investigator# 41128

    Los Angeles, California, 90048

  • Site Reference ID/Investigator# 41127

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 43182

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Read the detailed description

This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Being tested
ABT-450, ABT-072, Ribavirin, Ritonavir
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

    tablets

  • ABT-072Drug

    tablets

  • RibavirinDrug

    tablets

  • RitonavirDrug

    Also called Norvir

    capsules

Study groups in NCT01221298
Study groupRoleWhat they receive
ABT-450/r and ABT-072, plus ribavirin (RBV)ExperimentalABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Receives: Drug: ABT-450; Drug: ABT-072; Drug: Ribavirin; 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

    Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

    Measured: Week 4 through Week 12

Secondary outcomes (6)

  1. 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.

    Measured: Week 2

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

    Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).

    Measured: Week 4

  3. 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.

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

  4. 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.

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

  5. Time to Failure to Suppress or Rebound During Treatment

    The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.

    Measured: Day 1 through Week 12

  6. Time to Virologic Relapse Through 24 Weeks Post-treatment

    Time to 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.

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

Timeline

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

  1. First posted15 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMay 2011
  4. Study completionApr 2012

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221298
Sponsor's protocol ID
M12-267
Status last verified
Dec 2014
First submitted
13 Oct 2010
Last updated
8 Jan 2015
Data monitoring committee
No

Publications

  • Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.

    PubMed 23439262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-450, ABT-072 and Ribavirin in people with Hepatitis C and HCV, run by AbbVie (prior sponsor, Abbott) at 4 sites in United States.

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 6 inclusion and 9 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 8 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 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 (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 NCT01221298, which also lists 1 linked publication.

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 8 Jan 2015; AzTrials last refreshed its copy on 1 Nov 2026.

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