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Real World Study: Genotype 1 Chronic HCV Treatment and Evaluation of Real World SVR and PROs

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ClinicalTrials.gov Identifier: NCT02461745
Recruitment Status : Active, not recruiting
First Posted : June 3, 2015
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Kaiser Permanente

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, dasubuvir), with or without ribavirin.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: ombitasvir, paritaprevir/r, dasabuvir + ribavirin Drug: ombitasvir, paritaprevir/r, dasabuvir Phase 4

Detailed Description:

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 the AbbVie 3 direct-acting antiviral (3-DAA) regimen of VIEKIRA PAK (ombitasvir, paritaprevir/r, dasubuvir), with or without ribavirin.

Subjects may be treatment-naïve or treatment experienced with pegylated-interferon based regimens excluding regimens with direct-acting antiviral agents. The study will be conducted at multiple Kaiser Permanente Southern California Medical Centers.

The primary objective of this open label study is to evaluate the rate of sustained virological response rate 12 weeks after completion of treatment (SVR12) with VIEKIRA PAK, with or without ribavirin in a large real world setting.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Multisite Study of the Treatment of Chronic Hepatitis C Virus Infection Genotype 1 in a Real World Large Health Maintenance Organization: An Evaluation of Real World Sustained Virological Response and Patient Reported Outcomes
Study Start Date : June 2015
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Genotype 1a
ombitasvir, paritaprevir/r, dasabuvir + ribavirin
Drug: ombitasvir, paritaprevir/r, dasabuvir + ribavirin
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks
Other Name: VIEKIRA PAK + RBV

Active Comparator: Genotype 1b
ombitasvir, paritaprevir/r, dasabuvir
Drug: ombitasvir, paritaprevir/r, dasabuvir
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)
Other Name: VIEKIRA PAK




Primary Outcome Measures :
  1. Percentage of subjects achieving sustained virological response (SVR) at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of subjects achieving sustained virological response (SVR) at Week 4 [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • 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

Key Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461745


Locations
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United States, California
Kaiser Permanente Medical Center
Irvine, California, United States, 92618
Kaiser Permanente Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente Medical Center
San Diego, California, United States, 92154
Kaiser Permanente Medical Center
San Marcos, California, United States, 92078
Sponsors and Collaborators
Kaiser Permanente
AbbVie
Investigators
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Principal Investigator: Lisa M Nyberg, MD Kaiser Permanente

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02461745     History of Changes
Other Study ID Numbers: KPSC IRB 10568
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Keywords provided by Kaiser Permanente:
VIEKIRA PAK
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors