Hepatitis CNCT03111966
Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
An observational study of Hepatitis C, run by Hepa C at 1 site in Spain.
Trial summary
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 31 Mar 2017to 30 Nov 2017
- How long will I take part?
- 8 Months
- 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 HCV who are treated in real practice with Elbasvir/Grazoprevir
Who may be able to join
- Age: 18 years to 100 years (adult).
- Sexes: all
- Healthy volunteers: no
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).
Read the detailed description
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)
- Conditions
- Hepatitis C
- Being tested
- Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish cohort with HCV treated in real practice with Elbasvir/GrazoprevirOther
Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
| Study group | Role | What they receive |
|---|---|---|
| Spanish cohort with HCV treated with DAA | Not described Receives: Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response 12 weeks post-treatment (SVR12)
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12)
- Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
Measured: 12 weeks after the last dose of study drug
Secondary outcomes (3)
virologic failure
Percentage of patients with virologic failure during treatment
- Measure: Percentage of patients with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment or previous unquantifiable HCV up to 12 weeks after last dose of drug
Measured: Up to 8 weeks while on treatment
SVR 12 and patients with mild fibrosis
Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment
- Measure: percentage of patients with a baseline transient elastography < 6 kPa
Measured: Up to 12 weeks after last dose of study drug
low baseline viral load and SVR12
Percentage of participants with low baseline viral load who achieve sustained
- Measure: HCV RNA levels less than the lower limit of quantification.
Measured: Baseline and 12 weeks after the last dose of drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start31 Mar 2017
- Primary completion30 Apr 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Hepa C
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111966
- Sponsor's protocol ID
- 0001
- Status last verified
- Feb 2019
- First submitted
- 1 Apr 2017
- Last updated
- 11 Feb 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.
PubMed 30265418
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort
- ClinicalTrials.gov ID
- NCT03111966
- Acronym / sponsor ID
- 0001
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hepa CUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Apr 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.
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases).
Detailed description
This is a multicentre, descriptive, observational and ambispective study carried out in patients who are treated with Elbasvir/Grazoprevir in hospitals that included their data in Hepa-C Registry (directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish cohort with HCV treated with DAA | – | Other: Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCV who are treated in real practice with Elbasvir/Grazoprevir
Key inclusion criteria (4 listed)
- Age: 18 years to 100 years (adult).
- Sexes: all
- Healthy volunteers: no
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Spanish cohort with HCV treated in real practice with Elbasvir/GrazoprevirSpanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir | Other | Spanish cohort with HCV treated with DAA |
Primary outcome
sustained virological response 12 weeks post-treatment (SVR12)
Time frame: 12 weeks after the last dose of study drug
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.
3 secondary outcomes
virologic failure
Time frame: Up to 8 weeks while on treatment
SVR 12 and patients with mild fibrosis
Time frame: Up to 12 weeks after last dose of study drug
low baseline viral load and SVR12
Time frame: Baseline and 12 weeks after the last dose of drug
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 11 Feb 2019.
- Results publication: PubMed 30265418Hernandez-Conde M, Fernandez I, Perello C, Gallego A, Bonacci M, Pascasio JM, Romero-Gomez M, Llerena S, Fernandez-Rodriguez C, Castro Urda JL, Garcia Buey L, Carmona I, Morillas RM, Garcia ND, Gea F, Carrion JA, Castellote J, Moreno-Planas JM, Piqueras Alcol B, Molina E, Diago M, Montoliu S, de la Vega J, Menendez F, Sanchez Ruano JJ, Garcia-Samaniego J, Rosales-Zabal JM, Anton MD, Badia E, Souto-Rodriguez R, Salmeron FJ, Fernandez-Bermejo M, Figueruela B, Moreno-Palomares JJ, Calleja JL. Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort. J Viral Hepat. 2019 Jan;26(1):55-64. doi: 10.1111/jvh.13008. Epub 2018 Oct 25.
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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 Hepatitis C, run by Hepa C 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 4 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 11 Feb 2019. 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?
sustained virological response 12 weeks post-treatment (SVR12) (time frame: 12 weeks after the last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03111966, which also lists 1 linked publication.
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 11 Feb 2019.