PROPHESYS 2: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01066793
First received: February 9, 2010
Last updated: March 16, 2012
Last verified: March 2012
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Purpose
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) or peginterferon alfa-2b 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 <2000.
| 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 12 and 24 weeks after 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: | 2272 |
| Study Start Date: | October 2007 |
| 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
- informed consent to data collection
Exclusion Criteria:
- co-infection with HIV or HBV
- previous treatment with peginterferon and/or ribavirin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066793
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Hide Study LocationsLocations
| Belgium | |
| Aalst, Belgium, 9300 | |
| Antwerpen, Belgium, 2060 | |
| Antwerpen, Belgium, 2018 | |
| Brugge, Belgium, 8000 | |
| Bruxelles, Belgium, 1020 | |
| Bruxelles, Belgium, 1090 | |
| Bruxelles, Belgium, 1200 | |
| Bruxelles, Belgium, 1190 | |
| Bruxelles, Belgium, 1000 | |
| Bruxelles, Belgium, 1070 | |
| Charleroi, Belgium, 6000 | |
| Edegem, Belgium, 2650 | |
| Genk, Belgium, 3600 | |
| Gent, Belgium, 9000 | |
| Gilly, Belgium, 6060 | |
| Haine-saint-paul, Belgium, 7100 | |
| Kortrijk, Belgium, 8500 | |
| Leuven, Belgium, 3000 | |
| Liege, Belgium, 4000 | |
| Namur, Belgium, 5000 | |
| Oostende, Belgium, 8400 | |
| Roeselare, Belgium, 8800 | |
| Seraing, Belgium, 4100 | |
| Sijsele, Belgium, 8340 | |
| Tielt, Belgium, 8880 | |
| Verviers, Belgium, 4800 | |
| Yvoir, Belgium, 5530 | |
| Ireland | |
| Dublin, Ireland, 8 | |
| Dublin, Ireland, 4 | |
| Dublin, Ireland, 9 | |
| Italy | |
| Alessandria, Italy, 15100 | |
| Arezzo, Italy, 52100 | |
| Asti, Italy, 14100 | |
| Barra, Italy, 80147 | |
| Basovizza (ts), Italy, 34100 | |
| Benevento, Italy, 82100 | |
| Biella, Italy, 13900 | |
| Bisceglie, Italy, 70052 | |
| Bologna, Italy, 40138 | |
| Bolzano, Italy, 39100 | |
| Brescia, Italy, 25125 | |
| Brindisi, Italy, 72100 | |
| Busto Arsizio, Italy, 21052 | |
| Casarano, Italy, 73042 | |
| Castellana Grotte, Italy, 70013 | |
| Catania, Italy, 95126 | |
| Catanzaro, Italy, 88100 | |
| Comiso, Italy, 97013 | |
| Cremona, Italy, 26100 | |
| Fermo, Italy, 63023 | |
| Ferrara, Italy, 44100 | |
| Firenze, Italy, 50134 | |
| Foggia, Italy, 71100 | |
| Galatina, Italy, 73013 | |
| Gallarate, Italy, 21013 | |
| Gorizia, Italy, 34170 | |
| Gragnano, Italy, 80054 | |
| Grosseto, Italy, 58100 | |
| Isernia, Italy, 86170 | |
| Lecco, Italy, 23900 | |
| Livorno, Italy, 57124 | |
| Lucca, Italy, 55100 | |
| Messina, Italy, 98125 | |
| Mestre (ve), Italy, 30172 | |
| Milano, Italy, 20153 | |
| Milano, Italy, 20122 | |
| Milano, Italy, 20121 | |
| Milano, Italy, 20132 | |
| Milano, Italy, 20142 | |
| Monserrato, Italy, 09042 | |
| Monza, Italy, 20052 | |
| Napoli, Italy, 80136 | |
| Napoli, Italy, 80143 | |
| Napoli, Italy, 80137 | |
| Napoli, Italy, 80131 | |
| Napoli, Italy, 80138 | |
| Napoli, Italy, 80123 | |
| Napoli, Italy, 80141 | |
| Nola, Italy, 80035 | |
| Novara, Italy, 28100 | |
| Padova, Italy, 35128 | |
| Palermo, Italy, 90127 | |
| Parma, Italy, 43100 | |
| Perugia, Italy, 06123 | |
| Pescara, Italy, 65124 | |
| Roma, Italy, 00133 | |
| Roma, Italy, 00149 | |
| Roma, Italy, 00165 | |
| Roma, Italy, 00168 | |
| Roma, Italy, 00161 | |
| Roma, Italy, 00128 | |
| Roma, Italy, 00152 | |
| Saronno, Italy, 21047 | |
| Sassari, Italy, 07100 | |
| Savona, Italy, 17100 | |
| Taranto, Italy, 74100 | |
| Torino, Italy, 10128 | |
| Torino, Italy, 10126 | |
| Trento, Italy, 38100 | |
| Treviglio, Italy, 24047 | |
| Treviso, Italy, 31100 | |
| Udine, Italy, 33100 | |
| Venezia, Italy, 30122 | |
| Verona, Italy, 37134 | |
| Vibo Valentia, Italy, 89900 | |
| United Kingdom | |
| London, United Kingdom, NW3 2QG | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01066793 History of Changes |
| Other Study ID Numbers: | MV21020 |
| Study First Received: | February 9, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | Ireland: Irish Council for Bioethics |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Hepatitis, Chronic Peginterferon alfa-2a Interferon-alpha Peginterferon alfa-2b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013