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Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients (HepCC-2)

Primary Purpose

Hepatitis C

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sofosbuvir/Ledipasvir 12W
Sofosbuvir/Ledipasvir plus Ribavirin 12W
Sofosbuvir/Ledipasvir 24W
Sofosbuvir/Ledipasvir plus Ribavirin 24W
Sponsored by
Iran Hepatitis Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic HCV infection
  • >18 years old

Exclusion Criteria:

  • HIV co-infected
  • Liver transplanted
  • Receiving drugs with suspected interactions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Sofosbuvir/Ledipasvir for 12W

    Sofosbuvir/Ledipasvir+Ribavirin for 12W

    Sofosbuvir/Ledipasvir for 24W

    Sofosbuvir/Ledipasvir+Ribavirin for 24W

    Arm Description

    Patients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

    Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

    Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

    Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.

    Outcomes

    Primary Outcome Measures

    Sustained Virologic Response
    Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2017
    Last Updated
    February 17, 2017
    Sponsor
    Iran Hepatitis Network
    Collaborators
    Baqiyatallah Research Center for Gastroenterology and Liver Diseases
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03061032
    Brief Title
    Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
    Acronym
    HepCC-2
    Official Title
    Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2017 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Iran Hepatitis Network
    Collaborators
    Baqiyatallah Research Center for Gastroenterology and Liver Diseases

    4. Oversight

    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.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sofosbuvir/Ledipasvir for 12W
    Arm Type
    Experimental
    Arm Description
    Patients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
    Arm Title
    Sofosbuvir/Ledipasvir+Ribavirin for 12W
    Arm Type
    Experimental
    Arm Description
    Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.
    Arm Title
    Sofosbuvir/Ledipasvir for 24W
    Arm Type
    Experimental
    Arm Description
    Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
    Arm Title
    Sofosbuvir/Ledipasvir+Ribavirin for 24W
    Arm Type
    Experimental
    Arm Description
    Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sofosbuvir/Ledipasvir 12W
    Intervention Description
    Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sofosbuvir/Ledipasvir plus Ribavirin 12W
    Intervention Description
    Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sofosbuvir/Ledipasvir 24W
    Intervention Description
    Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sofosbuvir/Ledipasvir plus Ribavirin 24W
    Intervention Description
    Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
    Primary Outcome Measure Information:
    Title
    Sustained Virologic Response
    Description
    Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection
    Time Frame
    12 weeks after completion of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic HCV infection >18 years old Exclusion Criteria: HIV co-infected Liver transplanted Receiving drugs with suspected interactions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyed Moayed Alavian, MD
    Phone
    +989121073195
    Email
    alavian@thc.ir
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heidar Sharafi, PhD
    Phone
    +989125176030
    Email
    h.sharafi@meldcenter.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyed Moayed Alavian, MD
    Organizational Affiliation
    Iran Hepatitis Network
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Heidar Sharafi, PhD
    Organizational Affiliation
    Iran Hepatitis Network
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Bita Behnava, MD
    Organizational Affiliation
    Iran Hepatitis Network
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mohammad Saeid Rezaee-Zavareh, MD
    Organizational Affiliation
    Iran Hepatitis Network
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients

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