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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02762448
Enrollment
0
Registered
2016-05-05
Start date
2016-07-31
Completion date
2018-04-18
Last updated
2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis c

Brief summary

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

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

DRUGDaclatasvir+ Asunaprevir

HCV clearance and complete regression of NHL by ASV+ DCV

Sponsors

Tainan Municipal Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
HCV clearance and complete regression of NHL by ASV+ DCV2yearspatients 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026