NCT03342261

Brief Summary

Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

November 7, 2017

Last Update Submit

November 9, 2017

Conditions

Hepatitis C, ChronicMixed Cryoglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Cryoglobulin level at the end of therapy

    The primary outcome was the cryoglobulin level at the end of direct-acting antiviral treatment (week 12 or 24 according to treatment duration)

    End of treatment (12 or 24 weeks)

Study Arms (1)

HCV patients with mixed cryoglobulinemia

HCV patients with or without HIV presenting a mixed cryoglobulinemia and treated with direct-acting antiviral agents

Drug: DAA treatment

Interventions

DAA treatmentDRUG

Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks

Also known as: Treatment with direct-acting antiviral agents
HCV patients with mixed cryoglobulinemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HCV patients with mixed cryoglobulinemia

You may qualify if:

  • hepatitis C virus (HCV) infected patients
  • symptomatic or asymptomatic mixed cryoglobulinemia
  • coinfected or not with HIV
  • treated by direct-acting antiviral (DAA) treatment
  • at least one cryoglobulin measurement before and after DAA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Croix-Rousse Hospital

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hepatitis C, ChronicCryoglobulinemia, Familial Mixed

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fabien Zoulim, MD, PhD

    Hospices Civils de Lyon

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 14, 2017

Study Start

March 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)