An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447446
• Other study ID #: MV25599
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: July 1, 2016
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Syria: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in patients with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from patients receiving treatment according to current Summary of Product Characteristics and local labeling for the duration of their treatment and a 24-week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4429
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (according to local legislation) patients

• Chronic hepatitis C (HCV)

• Naïve or treatment experienced and HIV HCV co-infected

• Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion Criteria:

• Contraindications according to SPC/local labeling

• Treatment started >4 weeks before entering study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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

Countries where clinical trial is conducted

Belgium,  Egypt,  Estonia,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy,  Kuwait,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Morocco,  Oman,  Pakistan,  Portugal,  Qatar,  Romania,  Saudi Arabia,  Serbia,  Sweden,  Switzerland,  Syrian Arab Republic,  Taiwan,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks past completion of treatment		approximately 4 years	No
Secondary	Virological response (in correlation with on-treatment factors)		approximately 4 years	No
Secondary	Duration of treatment		approximately 4 years	No
Secondary	Percentage of patients treated according to label / Summary of Product Characteristics (SPC)		approximately 4 years	No
Secondary	Treatment discontinuation (time, reasons)		approximately 4 years	No
Secondary	Sustained virological response in correlation with dose reductions/treatment interruptions		approximately 4 years	No
Secondary	Treatment (drugs, regimen) in relation to medical history/concomitant medical conditions		approximately 4 years	No
Secondary	Incidence of viral rebound on DAA based triple therapy		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No