Chronic Hepatitis cEFINO-CNCT03346941
Side Effects After Direct-acting Antiviral Treatment
An observational study of Chronic Hepatitis c, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- DAA treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to 31 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C treated with direct-acting antiviral treatment
Who may be able to join
- 18 years of age or older
- Hepatitis C virus infection
- Treatment by direct-acting antiviral combination
Who cannot join
- HIV coinfection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.
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.
Read the detailed 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.
- Conditions
- Chronic Hepatitis c
- Being tested
- DAA treatment
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAA treatmentDrug
Direct-acting antiviral-based treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 May 2016
- Primary completion30 Sep 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346941
- Sponsor's protocol ID
- CRC_GHN_2017_004
- Acronym
- EFINO-C
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.
- ClinicalTrials.gov ID
- NCT03346941
- Acronym / sponsor ID
- EFINO-C / CRC_GHN_2017_004
- Conditions
- Chronic Hepatitis c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C treated with direct-acting antiviral treatment
Key inclusion criteria (3 listed)
- 18 years of age or older
- Hepatitis C virus infection
- Treatment by direct-acting antiviral combination
Key exclusion criteria (1 listed)
- HIV coinfection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAA treatmentDirect-acting antiviral-based treatment | Drug | – |
Primary outcome
Incidence of side effects
Time frame: Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation
Incidence of side effects occurring during treatment duration. Treatment duration may be of 8 weeks, 12 weeks or 24 weeks depending on treatment combination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis c
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"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis c, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of side effects (time frame: Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.