Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis (PIVOTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874066
Recruitment Status : Completed
First Posted : August 22, 2016
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent safety profiles to treat patients with severe renal impairment. With regard to ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1) study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b patients with severe renal impairment, the patient number was small and the data with regard to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b patients receiving hemodialysis.

Condition or disease Intervention/treatment Phase
Hepatitis Viruses Drug: PTV/r/OBV/DSV Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Paritaprevir/Ritonavir/Ombitasvir Plus Dasabuvir for Treatment-Naive and Treatment-Experienced Non-Cirrhotic Patients With Hepatitis C Virus Genotype 1b Receiving Hemodialysis
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : December 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PTV/r/OBV/DSV
Paritaprevir/ritonavir/ombitasvir (PTV/r/OBV, 75mg/50mg/12.5mg per tablet, Viekirax): 2 tablets per os per day Dasabuvir (DSV, 250 mg per tablet, Exviera): 1 tablet per os twice per day Treatment duration: 12 weeks
Drug: PTV/r/OBV/DSV
Viekirax/Exviera for 12 weeks
Other Name: Viekirax/Exviera




Primary Outcome Measures :
  1. Number of Participants With Sustained Virologic Response (SVR12) [ Time Frame: 24 weeks ]
    Number of participants with undetectable serum HCV RNA 12 weeks off therapy (treatment period 12 weeks)


Secondary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate [ Time Frame: 12 weeks ]
    Number of participants with treatment-emergent adverse event (AE)-related withdrawal rate during the study

  2. Number of Participants With Sustained Virologic Response (SVR24) [ Time Frame: 36 weeks ]
    Number of participants with undetectable serum HCV RNA 24 weeks off therapy (treatment period 12 weeks)

  3. Number of Participants With Rapid Virologic Response (RVR) [ Time Frame: 4 weeks ]
    Number of participants with undetectable serum HCV RNA at week 4 of treatment

  4. Number of Participants With End-of-treatment Virological Response (EOTVR) [ Time Frame: 12 weeks ]
    Number of participants with undetectable serum HCV RNA at week 12 of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages of 20 to 70 yeas
  • Male or female
  • Body mass index (BMI) 18.5-35.0 kg/m2
  • Chronic HCV infection, defined as patients who meet as least one of the two following criteria

    1. Anti-HCV antibody (Abbott HCV enzyme-linked immunosorbent assay [EIA] 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA > 1,000 IU/mL for at least 6 months before screening
    2. Positive HCV RNA > 1,0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics Gesellschaft mit beschränkter Haftung [GmbH], Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection
  • HCV GT-1b infection (Abbott RealTime HCV genotyping II, Abbott Molecular Inc. Illinois, USA)
  • Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies)
  • HCV RNA > 10,000 IU/mL at screening
  • Absence of cirrhosis with documented results of one of the following criteria:

    1. Liver biopsy within 24 months prior to or during screening demonstration the absence of cirrhosis, e.g. METAVIR score ≤ 3 or Ishak score ≤ 4.
    2. A screening transient elastography (Fibroscan) result of < 12.5 kilopascal (kPa)
    3. A screening Fibrosis Index Based on 4 markers (FIB-4) of ≤ 1.45 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of ≤ 2
    4. Subjects with non-qualifying FIB-4/APRI or Fibroscan result may only be enrolled if they have a qualifying liver biopsy within 24 months prior to or during screening
  • Estimated glomerular filtration (eGFR) rate < 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis

Exclusion Criteria:

  • HCV infection other than HCV GT-1b
  • Hepatitis B virus (HBV) or HIV co-infection
  • Presence of cirrhosis (Child-Puge class A, B or C)
  • Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following

    1. Hemochromatosis
    2. Alfa-1 antitrypsin deficiency
    3. Wilson's disease
    4. Autoimmune hepatitis
    5. Alcoholic liver disease
    6. Drug-induced hepatitis
  • Screening laboratory analyses showing any of the following results

    1. Hemoglobin (Hb) level < 10 g/dL
    2. Absolute neutrophil count (ANC) < 1,500 cells/μL
    3. Platelet count < 60,000 cells/mm3
    4. International normalized ratio (INR) > 2.0
    5. Albumin (Alb) < 2.8 g/dL
    6. Bilirubin (Bil) > 3.0 mg/dL
    7. Alanine aminotransferase (ALT) > 5X upper limit of normal (ULN)
    8. Aspartate aminotransferase (AST) > 5X upper limit of normal (ULN)
    9. Serum alfa-fetoprotein (AFP) > 100 ng/mL
  • Presence of hepatocellular carcinoma (HCC) on imaging studies such as computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • History of malignancy (except cutaneous melanoma) within 5 years at the screening
  • Organ transplantation other than cornea and hair (prior renal transplantation with graft failure not included)
  • Prior exposure to investigational agents for HCV (direct acting antiviral agents, host-targeting agents, or therapeutic vaccines)
  • Pregnancy
  • Unwilling to have contraception during the study period [12] Unwilling to provide informed consent

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): NCT02874066


Locations
Layout table for location information
Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei City Hospital, Ren-Ai Branch
Taipei, Taiwan
Tri-Service General Hospital, National Defense Medical Center
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
AbbVie
Investigators
Layout table for investigator information
Study Director: Chen-Hua Liu, MD, PhD National Taiwan University Hospital
  Study Documents (Full-Text)

Documents provided by National Taiwan University Hospital:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02874066    
Other Study ID Numbers: 201606016MIPC
First Posted: August 22, 2016    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Confidential of the individual participant data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Hepatitis C virus
Hemodialysis
Direct acting antiviral agents
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections