NCT03346941

Brief Summary

The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

November 15, 2017

Last Update Submit

November 15, 2017

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

  • Incidence of side effects

    Incidence of side effects occurring during treatment duration. Treatment duration may be of 8 weeks, 12 weeks or 24 weeks depending on treatment combination.

    Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation

Interventions

DAA treatmentDRUG

Direct-acting antiviral-based treatment

Eligibility Criteria

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

Patients with chronic hepatitis C treated with direct-acting antiviral treatment

You may qualify if:

  • years of age or older
  • Hepatitis C virus infection
  • Treatment by direct-acting antiviral combination

You may not qualify if:

  • HIV coinfection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

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 Design

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

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

May 1, 2016

Primary Completion

September 30, 2017

Study Completion

October 31, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)