NCT02106156

Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Noninterventional Study on the Quality Assurance of the Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys®) and Ribavirin (e.g. Copegus®) With Main Focus Gastroenterologists - a Project in BNG (Association of German Resident Gastroenterologists), Part III

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,228 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegylated interferon alfa-2a	Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
DRUG	Ribavirin	Ribavirin administered according to corresponding summary of product characteristics (SmPC).

Timeline

• Start date: 2008-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2014-04-08
• Last updated: 2016-09-23
• Results posted: 2016-09-23

Locations

1 site across 1 country: Germany