Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)

NCT02628717 | Completed

• 1 other identifier: I3MHCV
• Study Type: observational
• Target: 558
• Locations: 1 country
• Sites: 1

Brief Summary

Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)

Conditions

Chronic Hepatitis C; Cirrhosis

Keywords

Hepatitis C; sofosbuvir; ledipasvir; daclatasvir; simeprevir

Outcome Measures

Primary Outcomes (1)

• Number of patients with sustained virologic response (SVR)

  SVR is defined by the undetectability of HCV-RNA after 12 weeks of treatment free follow up

  12 weeks treatment free follow up

Secondary Outcomes (2)

• On treatment predictability of SVR

  12/24 weeks of treatment + 12 weeks of follow up

• Number of patients with liver events (Mortality, Hepatic decompensation, Variceal Bleeding,Hepatocellular Carcinoma, Need for Liver Transplantation) on longterm clinical outcome

  3 years

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  treatment (12 to 24 weeks) +12weeks treatment free follow up

Study Arms (4)

SOF/SMV

SOF/SMV 400mg/150mg QD 12-24 weeks

SOF/DCV

SOF/DCV 400mg/60mg QD 12-24 weeks

SOF/LDV

SOF/LDV 400mg/90mg QD 12-24 weeks

treatment duration

12 - 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with fibrosis grade F3 or F4, age \>18 years, with indication for antiviral treatment

You may qualify if:

• All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens

You may not qualify if:

• other disease with poor prognosis (ie. metastatic cancer, heart failure)
• participation in a clinical trial

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, A1090, Austria

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harald Hofer, MD,Prof

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: September 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

AU (1)