NCT02461745

Brief Summary

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

4 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

First Submitted

Initial submission to the registry

May 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

May 31, 2015

Results QC Date

July 16, 2018

Last Update Submit

January 21, 2021

Conditions

Hepatitis C, Chronic

Keywords

VIEKIRA PAK

Outcome Measures

Primary Outcomes (1)

  • Sustained Virological Response (SVR) at Week 12

    Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.

    12 weeks

Secondary Outcomes (1)

  • Sustained Virological Response (SVR) at Week 4

    4 weeks

Study Arms (2)

Genotype 1a

ACTIVE COMPARATOR

Study participants with chronic Hepatitis C Genotype 1A receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) and RBV (ribavirin tablets) for 12 weeks.

Drug: ombitasvir, paritaprevir/r, dasabuvir + ribavirin

Genotype 1b

ACTIVE COMPARATOR

Study participants with chronic Hepatitis C Genotype 1B receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) for 12 weeks.

Drug: ombitasvir, paritaprevir/r, dasabuvir

Interventions

ombitasvir, paritaprevir/r, dasabuvir + ribavirinDRUG

VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks

Also known as: VIEKIRA PAK + RBV
Genotype 1a
ombitasvir, paritaprevir/r, dasabuvirDRUG

VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)

Also known as: VIEKIRA PAK
Genotype 1b

Eligibility Criteria

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

You may qualify if:

  • Male or female at least 18 years of age at time of screening.
  • Subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment
  • Subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration
  • Subject must have at least one of the following indicators of chronic hepatitis C virus infection prior to study enrollment: Positive anti-HCV antibody or HCV RNA \> 10,000 IU/mL at least 6 months before screening, and positive for HCV RNA at the time of screening, or HCV RNA \> 10,000 IU/mL at screening and liver biopsy consistent with chronic HCV infection
  • Subject has a screening laboratory result indicating HCV genotype 1-infection

You may not qualify if:

  • Subject, if female is pregnant or is breastfeeding, of if male, with female partner who is currently pregnant
  • Subject has positive test result for hepatitis B surface antigen or confirmed positive anti-HIV antibody test
  • Subject received study contraindicated medications prior to study drug administration
  • Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug.
  • Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen
  • Current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin including previous exposure to ABT450 (paritaprevir) , ABT-267 (ombitasvir) or ABT-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration
  • Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
  • History of solid organ transplant
  • Evidence of cirrhosis
  • History of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy
  • Confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening
  • HCV genotype performed during screening indicates infection with any genotype other than genotype 1
  • Recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente Medical Center

Irvine, California, 92618, United States

Location

Kaiser Permanente Medical Center

Los Angeles, California, 90027, United States

Location

Kaiser Permanente Medical Center

San Diego, California, 92154, United States

Location

Kaiser Permanente Medical Center

San Marcos, California, 92078, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

ombitasvirdasabuvirRibavirinViekira Pak

Condition Hierarchy (Ancestors)

Hepatitis CBlood-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
Division of Clinical Trials Research
Organization
Southern California Permanente Medical Group
clinical.trials@kp.org
(626) 564-5667

Study Officials

  • Lisa M Nyberg, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2015

First Posted

June 3, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 22, 2021

Results First Posted

January 22, 2021

Record last verified: 2021-01

Locations

US(4)