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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
First received: October 4, 2011
Last updated: August 11, 2014
Last verified: August 2014

October 4, 2011
August 11, 2014
September 2011
November 2015   (final data collection date for primary outcome measure)
Sustained virological response rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks past completion of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01447446 on ClinicalTrials.gov Archive Site
  • Virological response (in correlation with on-treatment factors) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Duration of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Percentage of patients treated according to label / Summary of Product Characteristics (SPC) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Treatment discontinuation (time, reasons) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Sustained virological response in correlation with dose reductions/treatment interruptions [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Treatment (drugs, regimen) in relation to medical history/concomitant medical conditions [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of viral rebound on DAA based triple therapy [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
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

This prospective, multicenter, observational cohort study will evaluate the effi cacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatmen t regimens containing direct-acting antivirals in patients with chronic hepatiti s C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Da ta will be collected from patients receiving treatment according to current Summ ary of Product Characteristics and local labeling for the duration of their trea tment and a 24-week follow-up.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Chronic hepatitis C patients (naïve or treatment experienced and HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals

Hepatitis C, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: MV25599 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
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
 
NCT01447446
MV25599
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP