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

Hepatitis c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02762448
• Other study ID #: AI447-122
• Status: Withdrawn
• First received: April 28, 2016
• Last updated: April 17, 2018
• Start date: July 2016
• Est. completion date: April 18, 2018

Study information

• Verified date: April 2018
• Source: Tainan Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 18, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis c
• Lymphoma, Non-Hodgkin

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tainan Municipal Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV clearance and complete regression of NHL by ASV+ DCV	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	2years