Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas

Overview

Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Full Title of Study: “Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2018

Detailed Description

Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.

Interventions

  • Drug: Daclatasvir+ Asunaprevir
    • HCV clearance and complete regression of NHL by ASV+ DCV

Arms, Groups and Cohorts

  • Daclatasvir + Asunaprevir
    • Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks .

Clinical Trial Outcome Measures

Primary Measures

  • HCV clearance and complete regression of NHL by ASV+ DCV
    • Time Frame: 2years
    • patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment

Participating in This Clinical Trial

Inclusion Criteria

1. Men and women 2. 18 to 70 years of age 3. Who had chronic HCV genotype 1b infection 4. An HCV RNA level of 105 IU per milliliter or higher 5. Being diagnosed to be low grade B cell non-Hodgkin lymphoma Exclusion Criteria:

1. Patients with hepatitis B virus infection, 2. Other liver diseases 3. HIV infection, 4. Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N 5. Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tainan Municipal Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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