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

April 17, 2018 updated by: Tainan Municipal Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an open label pilot without control group or other intervention. Participants will be recruited to a known intervention. Assessments will be conducted in an unblinded fashion. In terms of genotypes, 1b and 2a were suggested to be risk factors for the developing lymphoma in most HCV patients. In HCV-infected patients with splenic marginal zone or indolent B-cell NHL, many studies reported that combined treatment with interferon-alpha and ribavirin may lead to HCV clearance and concomitant regression of lymphomas

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 .
Drug: Daclatasvir+ Asunaprevir
HCV clearance and complete regression of NHL by ASV+ DCV
Other Names:
  • DCV;ASV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tainan Municipal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis c

Clinical Trials on Daclatasvir+ Asunaprevir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe