NCT02762448

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

April 28, 2016

Last Update Submit

April 17, 2018

Conditions

Hepatitis c

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Daclatasvir+ AsunaprevirDRUG

HCV clearance and complete regression of NHL by ASV+ DCV

Also known as: DCV;ASV
Daclatasvir + Asunaprevir

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Men and women
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 5, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2018

Study Completion

April 18, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04