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Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03365635
Collaborator
Merck Sharp & Dohme LLC (Industry)
6
Enrollment
1
Location
6
Arms
11.3
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of candidate patients, application for insurance approval, specifics of direct acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring during and after therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
 Phase 4

Detailed Description

Background - Hepatitis C (HCV) is common in hemodialysis (HD) patients with reported prevalences of 25%, By 2020, predicted 775,000 hemodialysis patients in the US, of whom 109,000 will have HCV. Hepatitis C is associated with increased mortality in HD patients, decreased kidney allograft survival, and a source of nosocomial infection in hemodialysis units. Currently drugs to cure HCV - direct acting antivirals (DAA) which can be safely given to HD patients are now available. A significant portion of the medical care provided to HD patients is by Nephrologists and HD staff.

Goals of Protocol - 1. Provide guidelines for implementation and monitoring of DAA therapy in HD patients with HCV 2. Provide Nephrologists strategies for identification of candidate HD patients, obtainment of third party approval for DAA payment, specific drug dosing protocols based on genome type of HCV, and laboratory and clinical monitoring during DDA therapy. 3, By reducing the pool of HCV patients in a HD Unit, the risk of nosocomial transmission of HCV t o other patients and staff will be reduced

Study Design - an interventional, prospective, non-randomized, non-blinded trial to evaluate real world strategies to identify and treat HCV infected patients with Zepatier

Study Procedures 1. Patients who meet inclusion criteria without exclusion criteria be assigned treatment with Zepatier with or without Ribavirin according to following schedule: (a) Genotype 1a - treatment naive without NS5A polymorphism - Zepatier one tablet (100 mg grazoprevir and 50 mg elbasvir) per day for 12 weeks (b) Genotype 1a - treatment naiive with NS5A polymorphism - Zepatier one tablet daily and ribavirin (200 mg) daily for 16 weeks (c) Genotype 1b-treatment naive - Zepatier one daily for 12 weeks (d) Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - Zepatier and ribavirin each once daily for 12 weeks (e) Genotype 4 - treatment naive - Zepatier one daily for 12 weeks (f)Genotype 4 -prior treatment - Zepatier and ribavirin each once per day for 16 weeks

Baseline/Screening Testing: 1. HCV genotype testing 2. HCV viral RNA load 3. Liver function tests 4, Protime, Partial Thromboplastin time 5. HIV - if positive, then determine viral RNA and CD4 and T cell count 6. Liver biopsy (within 24 mo of treatment) or Fibroscan within 12 mo of treatment 7. Hepatitis BsAg 8. For patients with HCV genotype 1a, test fro NS5A mutation

Treatment of HIV/HCV co-infected patients will be done in collaboration with the HIV treating physician to determine if any adjustments in the HIV drug regimen will be required

Testing/Evaluations during Active DAA Treatment - 1. LFT and RNA HCV viral load at week 4, 8, and 12. For patients on 16 weeks of treatment, LFT at week 16 as well 2. For patients on combination Zepatier and ribavirin, hemoglobin monitoring every week during treatment 3. Clinical pharmacology evaluation for compliance and adverse events at week 4,8,and 12 (and week 16 for patients on 16 week treatment)

Testing/Evaluation Post DAA Treament - 1, RNA viral load at 12 weeks post treatment 2. Clinical Pharmacologoy evaluation 12 weeks post treatment for adverse events 3. patients who achieve sustained viral remission at 12 weeks will be identified in HD records as HCV ab positive but HCV viral load RNA negative

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
An interventional, prospective, non-randomized, non-blinded trial to evaluate real world strategies to identify and treat hepatitis C infected hemodialysis patients with ZepatierAn interventional, prospective, non-randomized, non-blinded trial to evaluate real world strategies to identify and treat hepatitis C infected hemodialysis patients with Zepatier
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"Real World" Administration of Zepatier (Grazoprevir Plus Elvasvir) in Chronic Hemodialysis Patients With Hepatitis C Infection. Strategies for Identification of Patients, Insurance Approval, Treatment , and Laboratory Monitoring
Actual Study Start Date :
Sep 22, 2019
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Genotype 1a -Rx naive -no NS5A polymorph

Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks

Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Same as described in arm description
Other Names:
  • Ribavirin 200 mg

    		•
    Experimental: Genotype 1a, Rx naive + NS5A polymorph

    Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks

    Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
    Same as described in arm description
    Other Names:
  • Ribavirin 200 mg

    		•
    Experimental: Genotype 1b - Rx naive

    Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

    Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
    Same as described in arm description
    Other Names:
  • Ribavirin 200 mg

    		•
    Experimental: Genotype 1a/1b -prior INF or NS3/4A

    Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks

    Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
    Same as described in arm description
    Other Names:
  • Ribavirin 200 mg

    		•
    Experimental: Genotype4 - treatment naive

    (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

    Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
    Same as described in arm description
    Other Names:
  • Ribavirin 200 mg

    		•
    Experimental: Genotype 4- prior treatment

    Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks

    Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
    Same as described in arm description
    Other Names:
  • Ribavirin 200 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. SVR - Sustained Virologic Response [12 weeks after completion of Elbasivir/Grazoprevir treatment]

      Absence of HCV by viral RNA quantitation at 12 weeks post treatment

    Secondary Outcome Measures

    1. Approval for DAA by Third Party Payers [Within one month of last patient enrolled]

      The number of participants for whom their third party insurance approved payment of the DAA (study drug)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Hemodialysis patient

    • age 18 years old

    • Hepatitis C antibody positive and Hepatitis C RNA Quantification positive

    • Hepatitis C genomes 1a, 1b, or 4

    • Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll

    • Not of reproductive potential - hemodialysis patients must have no menses for 12 months

    • Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment

    • Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

    Exclusion Criteria:

    • Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral

    • Have moderate or severe hepatic disease - Child-Pugh B or C

    • Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease

    • Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin

    • Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert

    • history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study

    • history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir

    • Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penn Presbyterian Medical Center Philadelphia Pennsylvania United States 19428

    Sponsors and Collaborators

    • University of Pennsylvania
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Michael R Rudnick, MD, University of Pennsylvania Health System

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Michael Rudnick, Principle Investigator, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03365635
    Other Study ID Numbers:
    • 828322
    First Posted:
    Dec 7, 2017
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Infections
    Hepatitis A
    Hepatitis C
    Cross Infection
    Hepatitis
    Ribavirin
    Grazoprevir
    Elbasvir-grazoprevir drug combination

    Study Results

    Participant Flow

    Recruitment Details Patients from an outpatient hemodialysis unit were recruited between October 2019 and April 2020
    Pre-assignment Detail There was no wash out or run-in period to this protocol
    Arm/Group Title Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Arm/Group Description Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
    Period Title: Overall Study
    STARTED 3 0 1 0 0 0
    COMPLETED 3 0 1 0 0 0
    NOT COMPLETED 0 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment Total
    Arm/Group Description Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Total of all reporting groups
    Overall Participants 3 0 1 0 0 0 4
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    NaN
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    0%
    Between 18 and 65 years
    0
    0%
    0
    NaN
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    >=65 years
    3
    100%
    0
    NaN
    1
    100%
    0
    NaN
    0
    NaN
    0
    NaN
    4
    100%
    Sex: Female, Male (Count of Participants)
    Female
    1
    33.3%
    0
    NaN
    1
    100%
    Male
    2
    66.7%
    1
    Infinity
    3
    300%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    NaN
    0
    0%
    Asian
    0
    0%
    0
    NaN
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    NaN
    0
    0%
    Black or African American
    3
    100%
    1
    Infinity
    4
    400%
    White
    0
    0%
    0
    NaN
    0
    0%
    More than one race
    0
    0%
    0
    NaN
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    NaN
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    3
    100%
    1
    Infinity
    4
    400%

    Outcome Measures

    1. Primary Outcome
    Title SVR - Sustained Virologic Response
    Description Absence of HCV by viral RNA quantitation at 12 weeks post treatment
    Time Frame 12 weeks after completion of Elbasivir/Grazoprevir treatment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Arm/Group Description Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
    Measure Participants 3 0 1 0 0 0
    Count of Participants [Participants]
    3
    100%
    0
    NaN
    1
    100%
    0
    NaN
    0
    NaN
    2. Secondary Outcome
    Title Approval for DAA by Third Party Payers
    Description The number of participants for whom their third party insurance approved payment of the DAA (study drug)
    Time Frame Within one month of last patient enrolled

    Outcome Measure Data

    Analysis Population Description
    No patients were recruited into some of the subgroups and this is noted as 0 participants for these subgroups
    Arm/Group Title Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Arm/Group Description Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
    Measure Participants 3 0 1 0 0 0
    Count of Participants [Participants]
    0
    0%
    0
    NaN

    Adverse Events

    Time Frame 24 weeks from start of therapy
    Adverse Event Reporting Description No definitions different than clinicaltrials.gov definitions. No adverse events
    Arm/Group Title Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Arm/Group Description Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description
    All Cause Mortality
    Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/0 (NaN) 0/1 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Serious Adverse Events
    Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/0 (NaN) 0/1 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1b - Rx Naive Genotype 1a/1b -Prior INF or NS3/4A Genotype4 - Treatment Naive Genotype 4- Prior Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/0 (NaN) 0/1 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    We anticipated screening 30 patients and enrolling 25 patients. However, there was a significant delay in the regulatory approvals for the protocol and during this delay period, many of the potential patients ultimately received direct acting antivirals from the primary care physicians or other physicians outside of Nephrology

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Michael R. Rudnick, MD
    Organization Penn Presbyterian Medical Center
    Phone 215-662-8738
    Email rudnickm@uphs.upenn.edu
    Responsible Party:
    Michael Rudnick, Principle Investigator, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03365635
    Other Study ID Numbers:
    • 828322
    First Posted:
    Dec 7, 2017
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Nov 1, 2021