Hepatitis C Infection3D8NCT03122132
Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks
An observational study of Hepatitis C Infection, run by Hepa C at 1 site in Spain.
Trial summary
The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2017to 1 Mar 2018
- 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 Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir
Who may be able to join
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
- Genotype 1b infection
- Treatment-naïve and non-cirrhotic
Who cannot join
- HCV genotype or subtype other than GT1b.
- Any current or past clinical evidence of cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.
The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
Read the detailed description
HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
- Conditions
- Hepatitis C Infection
- Being tested
- ombitasvir/paritaprevir/ritonavir 8 weeks, dasabuvir 8 weeks
- Keywords
- Hepatitis C Infection, Ombitasvir/Paritaprevir/Ritonavir+dasabuvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ombitasvir/paritaprevir/ritonavir 8 weeksDrug
Also called viekirax
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
dasabuvir 8 weeksDrug
Also called exviera
Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Spanish cohort with HCV treated with DAA | Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks Receives: Drug: ombitasvir/paritaprevir/ritonavir 8 weeks; Drug: dasabuvir 8 weeks |
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)
Percentage of patients with virologic failure during treatment
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
Measured: Up to 12 weeks after last dose of study drug
Mild fibrosis and sustained virological response 12 weeks post-treatment
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
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment
Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment
- 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 posted20 Apr 2017
- Study start20 Feb 2017
- Primary completion1 Jan 2018
- Study completion1 Mar 2018
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 C InfectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepa C
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122132
- Sponsor's protocol ID
- 0002
- Acronym
- 3D8
- Status last verified
- May 2018
- First submitted
- 11 Apr 2017
- Last updated
- 21 May 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12.
PubMed 30160363
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.
- ClinicalTrials.gov ID
- NCT03122132
- Acronym / sponsor ID
- 3D8 / 0002
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C Infection, Ombitasvir/Paritaprevir/Ritonavir+dasabuvir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hepa CUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 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.
The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
Detailed description
HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish cohort with HCV treated with DAA | – | Drug: ombitasvir/paritaprevir/ritonavir 8 weeks, Drug: dasabuvir 8 weeksSpanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks |
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 Ombitasvir/Paritaprevir/Ritonavir+Dasabuvir
Key inclusion criteria (3 listed)
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
- Genotype 1b infection
- Treatment-naïve and non-cirrhotic
Key exclusion criteria (2 listed)
- HCV genotype or subtype other than GT1b.
- Any current or past clinical evidence of cirrhosis.
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 |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir 8 weeksAlso: viekiraxSpanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks | Drug | Spanish cohort with HCV treated with DAA |
| dasabuvir 8 weeksAlso: exvieraSpanish cohort with HCV treated in real practice with dasabuvir 8 weeks | Drug | 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
Percentage of patients with virologic failure during treatment
Time frame: Up to 12 weeks after last dose of study drug
Mild fibrosis and sustained virological response 12 weeks post-treatment
Time frame: Up to 12 weeks after last dose of study drug
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment
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 21 May 2018.
- Derived from this study: PubMed 30160363Puigvehi M, De Cuenca B, Viu A, Diago M, Turnes J, Gea F, Pascasio JM, Lens S, Cabezas J, Badia E, Olveira A, Morillas RM, Torras X, Montoliu S, Cordero P, Castro JL, Salmeron J, Molina E, Sanchez-Ruano JJ, Moreno J, Anton MD, Moreno JM, De la Vega J, Calleja JL, Carrion JA. Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild-moderate fibrosis: Results from a real-world cohort. Liver Int. 2019 Jan;39(1):90-97. doi: 10.1111/liv.13950. Epub 2018 Nov 12.
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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 Infection, 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 3 inclusion and 2 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 21 May 2018. 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 NCT03122132, 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 21 May 2018.