PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01070550
First received: February 9, 2010
Last updated: May 5, 2015
Last verified: May 2015

February 9, 2010
May 5, 2015
June 2007
July 2011   (final data collection date for primary outcome measure)
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 end of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01070550 on ClinicalTrials.gov Archive Site
  • 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 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 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 end of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a)
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.

This observational study will assess predictors of early on-treatment and sustained virological response in treatment-naïve patients with chronic hepatitis C initiated on treatment with Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected during the treatment period (24 or 48 weeks) and 12 and 24 weeks after the end of treatment. Target sample size is <5000.

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

Patients receiving peginterferon alfa-2a treatment at a medical centre

Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician
Cohort
Intervention: Drug: peginterferon alfa-2a [Pegasys]
Ferenci P, Aires R, Ancuta I, Arohnson A, Cheinquer H, Delic D, Gschwantler M, Larrey D, Tallarico L, Schmitz M, Tatsch F, Ouzan D. A tool for selecting patients with a high probability of sustained virological response to peginterferon alfa-2a (40kD)/ribavirin. Liver Int. 2014 Nov;34(10):1550-9. doi: 10.1111/liv.12439. Epub 2014 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4598
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic hepatitis C
  • informed consent to data collection

Exclusion Criteria:

  • co-infection with HIV or HBV
  • previous treatment with peginterferon and/or ribavirin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Brazil,   Canada,   Croatia,   France,   Hungary,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Morocco,   Poland,   Romania,   Serbia,   Slovenia,   Sweden
 
NCT01070550
MV21012
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2015

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