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

Withdrawn

• Conditions: Hepatitis c
• Interventions: Drug: Daclatasvir+ Asunaprevir

• Registration Number: NCT02762448
• Lead Sponsor: Tainan Municipal Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-05
• Study Start: 2016-07
• Primary Completion: 2018-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Study Completion: 2018-04-18
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Daclatasvir + Asunaprevir	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 .

Primary Outcome Measures

Name	Time	Method
HCV clearance and complete regression of NHL by ASV+ DCV	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