NCT01306617

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

January 8, 2015

Completed
Last Updated

January 8, 2015

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

February 28, 2011

Results QC Date

December 29, 2014

Last Update Submit

December 29, 2014

Conditions

Chronic Hepatitis C InfectionHepatitis CHepatitis C Virus

Outcome Measures

Primary Outcomes (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).

    Week 4 through Week 12

Secondary Outcomes (11)

  • Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)

    Week 2

  • Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4

    Week 4

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

    Post-treatment Day 1 to Post-treatment Week 12

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

    Post-treatment Day 1 to Post-treatment Week 24

  • Time to Failure to Suppress or Rebound During Treatment

    Day 1 through Week 12

  • +6 more secondary outcomes

Study Arms (3)

ABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve

EXPERIMENTAL

ABT-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.

Drug: ABT-450Drug: ABT-333Drug: ribavirinDrug: ritonavir

ABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïve

EXPERIMENTAL

ABT-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.

Drug: ABT-450Drug: ABT-333Drug: ribavirinDrug: ritonavir

ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-responders

EXPERIMENTAL

ABT-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.

Drug: ABT-450Drug: ABT-333Drug: ribavirinDrug: ritonavir

Interventions

ABT-450DRUG

tablets

ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-respondersABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïveABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ABT-333DRUG

tablets

Also known as: dasabuvir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-respondersABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïveABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ribavirinDRUG

tablets

ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-respondersABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïveABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve
ritonavirDRUG

capsules

Also known as: Norvir
ABT-450/r (150/100 mg) and ABT-333 plus RBV in non-respondersABT-450/r (150/100 mg) and ABT-333 plus RBV in treatment-naïveABT-450/r (250/100 mg) and ABT-333 plus RBV in treatment-naïve

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Site Reference ID/Investigator# 48263

Los Angeles, California, 90048, United States

Location

Site Reference ID/Investigator# 48264

Aurora, Colorado, 80045, United States

Location

Site Reference ID/Investigator# 51282

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 50425

Springfield, Massachusetts, 01105, United States

Location

Site Reference ID/Investigator# 50423

Kansas City, Missouri, 64131, United States

Location

Site Reference ID/Investigator# 48268

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 50428

Statesville, North Carolina, 28677, United States

Location

Site Reference ID/Investigator# 48266

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 50427

Newport News, Virginia, 23602, United States

Location

Site Reference ID/Investigator# 48265

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 50424

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 23281975DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevirdasabuvirRibavirinRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie (prior sponsor, Abbott)
800-633-9110

Study Officials

  • Daniel Cohen, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

October 1, 2012

Last Updated

January 8, 2015

Results First Posted

January 8, 2015

Record last verified: 2014-12

Locations

US(11)