PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066819
First received: February 9, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This observational study will assess predictors of early on-treatment and sustai ned virological response in treatment-naïve patients with chronic hepatitis C in itiated on treatment with Pegasys (peginterferon alfa-2a) or peginterferon alfa- 2b and ribavirin. Data will be collected during the treatment period (24 or 48 w eeks) and 12 and 24 weeks after the end of treatment. Target sample size is <200 0.


Condition Intervention
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in a Cohort of Treatment naïve HCV-infected Patients Treated With Pegylated Interferons

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Predictive values of virological response 4 and 12 weeks after treatment initiation on sustained virological response (SVR) by HCV genotype [ Time Frame: weeks 4 and 12, and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification and confirmation of host-, virus- and treatment-related factors influencing viral response, SVR and relapse [ Time Frame: throughout treatment and 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Correlation between overall treatment duration/treatment duration after HCV RNA becomes negative and SVR by genotype [ Time Frame: assessed 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Correlation of cumulative ribavirin and peginterferon dose with SVR by genotype [ Time Frame: assessed 12 and 24 weeks after the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 1611
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician

  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 receiving peginterferon alfa treatment at a medical centre

Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis C
  • HIV HCV co-infection allowed
  • informed consent to data collection

Exclusion Criteria:

  • co-infection with HBV
  • previous treatment with peginterferon and/or ribavirin
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01066819

  Show 106 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: NCT01066819     History of Changes
Other Study ID Numbers: MV21542
Study First Received: February 9, 2010
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014