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
  Purpose

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.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4000
Study Start Date: September 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447446

Contacts
Contact: Reference Study ID Number: MV25599 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 283 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01447446     History of Changes
Other Study ID Numbers: MV25599
Study First Received: October 4, 2011
Last Updated: August 11, 2014
Health Authority: Syria: Ministry of Health

Additional relevant MeSH terms:
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 16, 2014