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NCT03346941 Clinical Trial

Side Effects After Direct-acting Antiviral Treatment

Chronic Hepatitis c Clinical Trial

— EFINO-C  

Official title:
Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03346941
Other study ID # CRC_GHN_2017_004
Secondary ID
Status Completed
Phase N/A
First received November 15, 2017
Last updated November 15, 2017
Start date May 1, 2016
Est. completion date October 31, 2017

Study information
Verified date November 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Direct-acting antiviral (DAA)-based treatments are today very effective The objective of this study was to assess the incidence of side effects after DAA therapy in patients with chronic hepatitis C virus infection.

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date October 31, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Hepatitis C virus infection

- Treatment by direct-acting antiviral combination

Exclusion Criteria:

- HIV coinfection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DAA treatment
Direct-acting antiviral-based treatment

Locations
Country Name City State
France Croix-Rousse Hospital, Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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