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

NCT ID: NCT02762448

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-04-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatitis c

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 .

Daclatasvir+ Asunaprevir

Intervention Type DRUG

HCV clearance and complete regression of NHL by ASV+ DCV

Interventions

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Daclatasvir+ Asunaprevir

HCV clearance and complete regression of NHL by ASV+ DCV

Intervention Type DRUG

Other Intervention Names

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DCV;ASV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tainan Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AI447-122

Identifier Type: -

Identifier Source: org_study_id

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