NCT02068222

Brief Summary

The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 2, 2017

Completed
Last Updated

February 22, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

February 19, 2014

Results QC Date

December 9, 2016

Last Update Submit

January 25, 2018

Conditions

Chronic Hepatitis CHepatitis C Virus

Keywords

Hepatitis CHCVInterferon FreeChronic Hepatitis CHepatitis C virusHepatitis C Genotype 3

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)

    SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.

    12 weeks after last dose of study drug

Secondary Outcomes (3)

  • The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)

    24 weeks after last dose of study drug

  • The Percentage of Subjects With Virologic Failure During Treatment

    Up to Treatment Week 12

  • The Percentage of Subjects With Post-Treatment Relapse

    Within 12 weeks after the last dose of study drug

Study Arms (1)

ABT-450/r and ABT-530 plus RBV

EXPERIMENTAL

ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.

Drug: ABT-450/ritonavir (r)Drug: ABT-530Drug: Ribavirin (RBV)

Interventions

ABT-450/ritonavir (r)DRUG

Tablet

Also known as: ABT-450 also known as paritaprevir
ABT-450/r and ABT-530 plus RBV
ABT-530DRUG

Tablet

Also known as: pibrentasvir
ABT-450/r and ABT-530 plus RBV
Ribavirin (RBV)DRUG

Tablet

ABT-450/r and ABT-530 plus RBV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to \<38 kg/m2.
  • Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV.
  • Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening.
  • Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.

You may not qualify if:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
  • Prior therapy for the treatment of HCV.
  • Any current or past clinical evidence of cirrhosis.
  • Any cause of liver disease other than chronic HCV-infection.
  • HCV genotype co-infection with any other HCV genotype.
  • Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.

    PMID: 26778412RESULT

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

paritaprevirpibrentasvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Global Medical Information
Organization
AbbVie
800-633-9110

Study Officials

  • Armen Asatryan, 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 22, 2018

Results First Posted

February 2, 2017

Record last verified: 2018-01