Hepatitis C, ChronicHepatitisNCT05062408
Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals
An observational study of Hepatitis C, Chronic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 321 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are patients with chronic hepatitis C who have been treated with direct-acting antivirals between 2014 and 2017. Also patients with fibrosis and liver cirrhosis.
Who may be able to join
- Patients with chronic liver disease caused by virus C.
- Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
- Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan> 10 kPa, an APRI index> 1.5 and / or a FIB-4 index> 3.25. For its part, cirrhosis was defined such as a Fibroscan> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.
Who cannot join
- Coinfection by virus B or HIV.
- Development of HCC before or during treatment.
- Abuse of alcohol intake or addiction to parenteral drugs.
- Liver disease of non-viral etiology (autoimmune, toxic, metabolic).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals
The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.
Read the detailed description
This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.
- Conditions
- Hepatitis C, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| cases | Patients treated with direct-acting antivirals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a progression of liver injury.
To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals.
Measured: Up to 4 weeks
Secondary outcomes (4)
Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.
Development of hepatic decompensation, defined as a patient with ascites, spontaneous bacterial peritonitis (PBR), digestive bleeding of varicose origin, or hepatic encephalopathy at some point in the evolution from SVR until the end of study follow-up.
Measured: Up to 4 weeks.
Rate of risk factors presented by patients.
Identify risk factors in patients who develop liver complications after achieving sustained viral response.
Measured: Up to 4 weeks.
Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.
To determine if there is a relationship between the absence of improvement in non-invasive fibrosis parameters and the development of liver complications.
Measured: Up to 4 weeks.
Clinical and fibrosis data.
To compare the clinical and fibrosis data between patients who develop liver complications and those who do not.
Measured: Up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Mar 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Fernández Álvarez, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062408
- Sponsor's protocol ID
- FIS-ANT- 2021-01
- Acronym
- Hepatitis
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals
- ClinicalTrials.gov ID
- NCT05062408
- Acronym / sponsor ID
- Hepatitis / FIS-ANT- 2021-01
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 Sep 2021 (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 purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.
Detailed description
This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | –Patients treated with direct-acting antivirals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are patients with chronic hepatitis C who have been treated with direct-acting antivirals between 2014 and 2017. Also patients with fibrosis and liver cirrhosis.
Key inclusion criteria (3 listed)
- Patients with chronic liver disease caused by virus C.
- Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
- Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan> 10 kPa, an APRI index> 1.5 and / or a FIB-4 index> 3.25. For its part, cirrhosis was defined such as a Fibroscan> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.
Key exclusion criteria (4 listed)
- Coinfection by virus B or HIV.
- Development of HCC before or during treatment.
- Abuse of alcohol intake or addiction to parenteral drugs.
- Liver disease of non-viral etiology (autoimmune, toxic, metabolic).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with a progression of liver injury.
Time frame: Up to 4 weeks
To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals.
4 secondary outcomes
Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.
Time frame: Up to 4 weeks.
Rate of risk factors presented by patients.
Time frame: Up to 4 weeks.
Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.
Time frame: Up to 4 weeks.
Clinical and fibrosis data.
Time frame: Up to 4 weeks.
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 17 Nov 2021.
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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.
Paula Fernández Álvarez principal investigator
Hospital Universitario Virgen Macarena
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 Hepatitis C, Chronic, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 4 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 17 Nov 2021. 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 Spain. 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?
Number of patients with a progression of liver injury. (time frame: Up to 4 weeks). 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 17 Nov 2021.