A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Hepatitis C, Chronic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556307
• Other study ID #: ML22263
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: January 18, 2016
• Start date: March 2009
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Slovenia: Javna agencija Republike Slovenije za zdravila in medicinske pripomocke (JAZMP)
• Study type: Observational

Clinical Trial Summary

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients >/= 18 years

• Positive test for HCV

• Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion Criteria:

• Concomitant infection with HIV or hepatitis B

• Participation in a clinical trial within 30 days prior to study start

• Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.
• Ribavirin
Ribavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment	SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).	6 months after the last study drug administration (up to 123.6 weeks)	No
Secondary	Percentage of Participants With Undetectable HCV RNA	Undetectable HCV RNA=a single last HCV RNA <20 IU/mL	Weeks 4, 12 and at end of treatment (up to 99.6 weeks)	No
Secondary	HCV RNA Values		Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)	No
Secondary	Thrombocyte Values		Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)	No
Secondary	Leukocyte Values		Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)	No
Secondary	Hemoglobin Values		Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)	No
Secondary	Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin		Up to 99.6 Weeks	No