Impact of Antiviral Therapy on Gastroesophageal Varices.

Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758509
• Other study ID #: PROGRESSIVE-C
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: October 15, 2017

Study information

• Verified date: May 2018
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Negative to provide signed informed consent.

• Negative to perform gastrointestinal endoscopy

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated interferon alfa-2a + Ribavirin

• Pegylated interferon alfa-2a + Ribavirin + Boceprevir

• Pegylated interferon alfa-2a + Ribavirin +Telaprevir

• Ledipasvir/Sofosbuvir

• Ombitasvir/paritaprevir/ritonavir+Dasabuvir

• Daclatasvir+Sofosbuvir

• Simeprevir+Sofosbuvir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sustained virological response (SVR)	undetectable HCV viral load 12 weeks after the end of antiviral treatment in each cohort of antiviral treatment	12 weeks after treatment completion
Secondary	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	gastroesophageal varices (GOV) before antiviral treatment and 12-24 weeks after treatment completion