Chronic Hepatitis CNCT02758509
Impact of Antiviral Therapy on Gastroesophageal Varices.
An observational study of Chronic Hepatitis C and Cirrhosis, run by Parc de Salut Mar.
Trial summary
Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Cirrhosis
- What is being tested?
- Pegylated interferon alfa-2a + Ribavirin, Pegylated interferon alfa-2a + Ribavirin + Boceprevir and Pegylated interferon alfa-2a + Ribavirin +Telaprevir
- Type of treatment
- Pill or oral medicine
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 15 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 by genotype 1 and liver cirrhosis
Who may be able to join
- Age ≥ 18 years.
- Signed informed consent.
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
- Liver cirrhosis (transient elastography ≥ 14 kPa).
- Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices
Who cannot join
- Negative to provide signed informed consent.
- Negative to perform gastrointestinal endoscopy
About this study
Official title: Efficacy and Safety of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.
Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).
- Conditions
- Chronic Hepatitis C, Cirrhosis
- Being tested
- Pegylated interferon alfa-2a + Ribavirin, Pegylated interferon alfa-2a + Ribavirin + Boceprevir, Pegylated interferon alfa-2a + Ribavirin +Telaprevir, Ledipasvir/Sofosbuvir, Ombitasvir/paritaprevir/ritonavir+Dasabuvir
- Medical subject headings
- Hepatitis C, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alfa-2a + RibavirinDrug
Pegylated interferon alfa-2a + Ribavirin + BoceprevirDrug
Pegylated interferon alfa-2a + Ribavirin +TelaprevirDrug
Ledipasvir/SofosbuvirDrug
Ombitasvir/paritaprevir/ritonavir+DasabuvirDrug
Daclatasvir+SofosbuvirDrug
Simeprevir+SofosbuvirDrug
| Study group | Role | What they receive |
|---|---|---|
| PEG/RBV | Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011) Receives: Drug: Pegylated interferon alfa-2a + Ribavirin | |
| PEG/RBV+BOC or TVR | Boceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014) Receives: Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir; Drug: Pegylated interferon alfa-2a + Ribavirin +Telaprevir | |
| IF-DAAs | Interferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015)
* Fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg) daily +/- ribavirin 12-24 weeks
* Fixed-dose combination of ombitasvir (75 mg), paritaprevir (12.5 mg) and ritonavir (50 mg) in one single tablet (two tablets once daily) and dasabuvir (250 mg) (one tablet twice daily) with ribavirin 800-1200 mg 12 weeks (Genotype 1b) or 24 weeks (genotype 1a)
* Daily sofosbuvir (400 mg) and daily simeprevir (150 mg) +/- ribavirin 12-24 weeks
* Daily sofosbuvir (400 mg) and daily daclatasvir (60 mg) +/- ribavirin 12-24 weeks Receives: Drug: Ledipasvir/Sofosbuvir; Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir; Drug: Daclatasvir+Sofosbuvir; Drug: Simeprevir+Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response (SVR)
undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment
Measured: 12 weeks after treatment completion
Secondary outcomes (1)
Number of patients with gastroesophageal varices
Number of patients with GOV before and 12-24 weeks after treatment completion in patients with or without SVR
Measured: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start1 Jan 2010
- Primary completion15 Jun 2017
- Study completion15 Oct 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 Chronic 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Antonio Carrion, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758509
- Sponsor's protocol ID
- PROGRESSIVE-C
- Status last verified
- May 2018
- First submitted
- 26 Apr 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Puigvehi M, Londono MC, Torras X, Lorente S, Vergara M, Morillas RM, Masnou H, Serrano T, Miquel M, Gallego A, Lens S, Carrion JA. Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients. J Gastroenterol. 2020 Feb;55(2):205-216. doi: 10.1007/s00535-019-01619-0. Epub 2019 Sep 6.
PubMed 31493238
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 of Interferon Based Therapy and Interferon-free Direct-acting Antivirals in Cirrhotic Patients With Hepatitis C. Impact of Antiviral Therapy on Gastroesophageal Varices.
- ClinicalTrials.gov ID
- NCT02758509
- Acronym / sponsor ID
- PROGRESSIVE-C
- Conditions
- Chronic Hepatitis C, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jan 2010
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
Hepatitis C virus (HCV) chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The use of pegylated interferon (PEG-INF) with ribavirin (RBV) has supposed high serious adverse events (SAEs) and low efficacy, especially in patients with cirrhosis. The introduction of 1st generation protease inhibitors (PIs) in genotype-1 (GT1) HCV, such as boceprevir (BOC) and telaprevir (TVR), improved the efficacy but increased the SAEs. Currently, interferon-free direct-acting antivirals (IF-DAAs) achieve great effectiveness with minimum SAEs. However, studies evaluating efficacy and safety of DAAs in cirrhotic patients are limited in real clinical practice. The aim of our study is to evaluate in HCV-cirrhotic patients the efficacy and safety of 3 treatment strategies (PEG-IFN/RBV, PEG-IFN/RBV/PIs, and IF-DAAs) in routine practice according to European guidelines from 2010 to 2015. The secondary aim is to evaluate the impact of sustained virological response on gastroesophageal varices (GOV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG/RBV | – | Drug: Pegylated interferon alfa-2a + RibavirinPegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2011) |
| PEG/RBV+BOC or TVR | – | Drug: Pegylated interferon alfa-2a + Ribavirin + Boceprevir, Drug: Pegylated interferon alfa-2a + Ribavirin +TelaprevirBoceprevir 800 mg/8h or Telaprevir 750 mg/8h plus Pegylated interferon alfa-2a 180 microg/week plus ribavirin 800-1200 mg during 48 weeks according to routine practice and European Guidelines (EASL recommendations 2014) |
| IF-DAAs | – | Drug: Ledipasvir/Sofosbuvir, Drug: Ombitasvir/paritaprevir/ritonavir+Dasabuvir, Drug: Daclatasvir+Sofosbuvir, Drug: Simeprevir+SofosbuvirInterferon-free direct-acting antiviral combinations according to routine practice and European Guidelines (EASL recommendations 2015) * Fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg) daily +/- ribavirin 12-24 weeks * Fixed-dose combination of ombitasvir (75 mg), paritaprevir (12.5 mg) and ritonavir (50 mg) in one single tablet (two tablets once daily) and dasabuvir (250 mg) (one tablet twice daily) with ribavirin 800-1200 mg 12 weeks (Genotype 1b) or 24 weeks (genotype 1a) * Daily sofosbuvir (400 mg) and daily simeprevir (150 mg) +/- ribavirin 12-24 weeks * Daily sofosbuvir (400 mg) and daily daclatasvir (60 mg) +/- ribavirin 12-24 weeks |
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 by genotype 1 and liver cirrhosis
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Signed informed consent.
- Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
- Liver cirrhosis (transient elastography ≥ 14 kPa).
- Baseline upper gastrointestinal endoscopy to assess gastroesophageal varices
Key exclusion criteria (2 listed)
- Negative to provide signed informed consent.
- Negative to perform gastrointestinal endoscopy
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 |
|---|---|---|
| Pegylated interferon alfa-2a + Ribavirin | Drug | PEG/RBV |
| Pegylated interferon alfa-2a + Ribavirin + Boceprevir | Drug | PEG/RBV+BOC or TVR |
| Pegylated interferon alfa-2a + Ribavirin +Telaprevir | Drug | PEG/RBV+BOC or TVR |
| Ledipasvir/Sofosbuvir | Drug | IF-DAAs |
| Ombitasvir/paritaprevir/ritonavir+Dasabuvir | Drug | IF-DAAs |
| Daclatasvir+Sofosbuvir | Drug | IF-DAAs |
| Simeprevir+Sofosbuvir | Drug | IF-DAAs |
Primary outcome
sustained virological response (SVR)
Time frame: 12 weeks after treatment completion
undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment
1 secondary outcome
Number of patients with gastroesophageal varices
Time frame: gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion
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 31493238Puigvehi M, Londono MC, Torras X, Lorente S, Vergara M, Morillas RM, Masnou H, Serrano T, Miquel M, Gallego A, Lens S, Carrion JA. Impact of sustained virological response with DAAs on gastroesophageal varices and Baveno criteria in HCV-cirrhotic patients. J Gastroenterol. 2020 Feb;55(2):205-216. doi: 10.1007/s00535-019-01619-0. Epub 2019 Sep 6.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C and Cirrhosis, run by Parc de Salut Mar.
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 5 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.
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 (SVR) (time frame: 12 weeks after treatment completion). 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 NCT02758509, 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.