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Chronic Hepatitis C InfectionPhase 2NCT01306617

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Phase 2 study testing ABT-450, ABT-333 and ribavirin in people with Chronic Hepatitis C Infection and Hepatitis C, run by AbbVie (prior sponsor, Abbott) at 11 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 antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
ABT-450, 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
50 participants
Where
11 sitesUnited States
Study dates
Feb 2011to Oct 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 virus (HCV)
  • Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
  • Males and females 18-65 years old
  • Body mass index 18 to < 35 kg/m^2
  • Females must be postmenopausal for at least 2 years or surgically sterile

Who cannot join

  • Cirrhosis or extensive bridging fibrosis
  • History of cardiac disease
  • Positive screen for certain drugs or alcohol
  • Abnormal laboratory results
  • Significant sensitivity to any drug
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Site Reference ID/Investigator# 48264

    Aurora, Colorado, 80045

  • Site Reference ID/Investigator# 51282

    Gainesville, Florida, 32610

  • Site Reference ID/Investigator# 50423

    Kansas City, Missouri, 64131

  • Site Reference ID/Investigator# 48263

    Los Angeles, California, 90048

  • Site Reference ID/Investigator# 50424

    Madison, Wisconsin, 53792

  • Site Reference ID/Investigator# 48268

    New York, New York, 10016

  • Site Reference ID/Investigator# 50427

    Newport News, Virginia, 23602

  • Site Reference ID/Investigator# 48266

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 48265

    Seattle, Washington, 98101

  • Site Reference ID/Investigator# 50425

    Springfield, Massachusetts, 01105

  • Site Reference ID/Investigator# 50428

    Statesville, North Carolina, 28677

Other trials in United States

About this study

Official title: An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Read the detailed description

This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Being tested
ABT-450, ABT-333, 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-333Drug

    Also called dasabuvir

    tablets

  • ribavirinDrug

    tablets

  • ritonavirDrug

    Also called Norvir

    capsules

Study groups in NCT01306617
Study groupRoleWhat they receive
ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïveExperimentalABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
Receives: Drug: ABT-450; Drug: ABT-333; Drug: ribavirin; Drug: ritonavir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïveExperimentalABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
Receives: Drug: ABT-450; Drug: ABT-333; Drug: ribavirin; Drug: ritonavir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-respondersExperimentalABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
Receives: Drug: ABT-450; Drug: ABT-333; 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 Detection (LLOD) From Week 4 Through Week 12

    Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).

    Measured: Week 4 through Week 12

Secondary outcomes (11)

  1. Percentage of Participants With HCV 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 HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) 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

    Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.

    Measured: Day 1 through Week 12

  6. Time to Virologic Relapse Post-treatment

    Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (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 48

  7. Resistance-Associated Variants and Phenotypic Resistance

    Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.

    Measured: Day 1 to post-treatment week 48

  8. Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants

    Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

    Measured: Day 1 to Week 12

  9. Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants

    Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

    Measured: Day 1 to Week 12

  10. Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants

    Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

    Measured: Day 1 to Week 12

  11. Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants

    Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.

    Measured: Day 1 to Week 12

Timeline

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

  1. First posted2 Mar 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2011
  4. Study completionOct 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
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01306617
Sponsor's protocol ID
M12-746
Status last verified
Dec 2014
First submitted
28 Feb 2011
Last updated
8 Jan 2015
Data monitoring committee
No

Publications

  • Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):45-53. doi: 10.1056/NEJMoa1208809.

    PubMed 23281975

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-450, ABT-333 and ribavirin in people with Chronic Hepatitis C Infection and Hepatitis C, run by AbbVie (prior sponsor, Abbott) at 11 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 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 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 11 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 Detection (LLOD) 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 NCT01306617, 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.

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