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An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01508130
First received: January 9, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional, Prospective Cohort Study of the Effectiveness, Safety and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Time to premature treatment discontinuation due to any reason [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Efficacy: Sustained virological response rate, defined as percentage of patients with undetectable HCV RNA (HCV RNA </= 50 IU/mL) at 24 weeks post-completion of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response in correlation with baseline clinical/demographic patient characteristics [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Virological response in correlation with treatment (regimen/dosage/compliance/co-medication) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Treatment duration according to treatment regimens [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Percentage of patients treated according to US labeling [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Occurrence of premature discontinuation of treatment according to reasons (VR/resistance development/AE/compliance) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Association between degree of dose reductions/treatment interruptions and sustained virological response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Occurrence of virological rebound [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Virological response/virological rebound in correlation with hepatitis C virus genotype [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Virological response in relation to treatment duration after becoming HCV RNA undetectable [ 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 ]
  • Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 669
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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

Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C, genotype 1
  • Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

Exclusion Criteria:

  • Contraindications per US labels
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508130

  Show 63 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: NCT01508130     History of Changes
Other Study ID Numbers: ML27900
Study First Received: January 9, 2012
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013