- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762448
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
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:
- Men and women
- 18 to 70 years of age
- Who had chronic HCV genotype 1b infection
- An HCV RNA level of 105 IU per milliliter or higher
- Being diagnosed to be low grade B cell non-Hodgkin lymphoma
Exclusion Criteria:
- Patients with hepatitis B virus infection,
- Other liver diseases
- HIV infection,
- Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
- 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 .
|
HCV clearance and complete regression of NHL by ASV+ DCV
Other Names:
|
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
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
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Lymphoma
- Hepatitis
- Hepatitis C
- Lymphoma, Non-Hodgkin
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Asunaprevir
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.
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