Observational Study Evaluating the Quality of Pegasys and Copegus Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)

Chronic Hepatitis C Clinical Trial

Official title:

Noninterventional Study for Quality Assurance in Therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa-2a (Pegasys) and Ri-bavirin (i.e. Copegus) at Hepatology Centers- a Project in Cooperation With BNG (Association of German Resident Gastroenterologists, Part III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106156
• Other study ID #: ML21645
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: June 1, 2016
• Start date: January 2008
• Est. completion date: December 2013

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9729
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or over

• Clinically diagnosed CHC with detectable virus replication

• Use of effective contraception as defined in the protocol throughout the study until 4 months after end of treatment

Exclusion Criteria:

• Any contraindications for Pegasys or ribavirin treatment

• Pregnant or breast-feeding

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rapid virologic response (RVR)		1.5 years	No
Primary	Early virologic response (EVR)		1.5 years	No
Primary	End of treatment response (EOT)		1.5 years	No
Primary	Sustained virologic response (SVR)		1.5 years	No
Primary	Incidence of severe adverse events		1.5 years	No
Secondary	Patient demographics		At Baseline (Day 1)	No
Secondary	Hepatitis C medical history		At Baseline (Day 1)	No
Secondary	Treatment/dosage data		1.5 years	No
Secondary	Viral genotype		1.5 years	No
Secondary	Viral load		1.5 years	No
Secondary	Concomitant treatment information (medication type, dosage)		1.5 years	No