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: October 13, 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) and ribavirin. Data wi ll 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.


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 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 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 ]

Enrollment: 4598
Study Start Date: June 2007
Study Completion Date: July 2011
Primary Completion Date: July 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-2a 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
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: NCT01070550

  Hide Study Locations
Locations
Austria
Gratwein, Austria, 8112
Graz, Austria, 8036
Innsbruck, Austria, 6020
Linz, Austria, 4010
Linz, Austria, 4020
Oberndorf, Austria, 5110
Wien, Austria, 1030
Wien, Austria, 1090
Wien, Austria, 1160
Wien, Austria, 1100
Brazil
Salvador, BA, Brazil, 41110-170
Goiania, GO, Brazil, 74535170
Belo Horizonte, MG, Brazil, 31270-901
Belem, PA, Brazil, 66035-080
Recife, PE, Brazil, 50100-130
Recife, PE, Brazil, 50670-420
Rio de Janeiro, RJ, Brazil, 21041-030
Rio de Janeiro, RJ, Brazil, 20529-900
Rio de Janeiro, RJ, Brazil, 20270-004
Porto Alegre, RS, Brazil, 90035-003
Rio Grande, RS, Brazil, 96200-310
Botucatu, SP, Brazil, 18600-400
Campinas, SP, Brazil, 13026-210
Campinas, SP, Brazil, 13083-888
Ribeirao Preto, SP, Brazil, 14085-410
Santos, SP, Brazil, 11045-904
Santos, SP, Brazil, 11015470
Sao Paulo, SP, Brazil, 04039-901
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 05403-000
Sao Paulo, SP, Brazil, 04040-002
Sao Paulo, SP, Brazil, 01246-000
Canada, Alberta
Calgary, Alberta, Canada, T2G 0H5
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 1T2
Nanaimo, British Columbia, Canada, V9R 5N9
New Westminster, British Columbia, Canada, V3L 3W5
Prince George, British Columbia, Canada, V2M 5J6
Vancouver, British Columbia, Canada, V6Z 2C7
Victoria, British Columbia, Canada, V8R 6R3
Canada, Manitoba
Winnipeg, Manitoba, Canada, R2W 5L4
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1E 2Z1
Canada, Ontario
Barrie, Ontario, Canada, L4M 5G1
Brampton, Ontario, Canada, L6S 1C0
Etobicoke, Ontario, Canada, M9V 4B8
Guelph, Ontario, Canada, N1E 6Z1
London, Ontario, Canada, N6A 5R9
Newmarket, Ontario, Canada, L3Y 2P6
North Bay, Ontario, Canada, P1B 2H3
Oakville, Ontario, Canada, L6J 1X8
Oshawa, Ontario, Canada, L1G 2B9
Oshawa, Ontario, Canada, L1J 2J9
Ottawa, Ontario, Canada, K2B 8E8
Scarborough, Ontario, Canada, M1T 3V3
Sudbury, Ontario, Canada, P3E 1B8
Toronto, Ontario, Canada, M1S 4T7
Toronto, Ontario, Canada, M5A 1L5
Toronto, Ontario, Canada, M6A 3B2
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Levis, Quebec, Canada, G6V 3Z1
Montreal, Quebec, Canada, H2L 5B1
Montreal, Quebec, Canada, H2L 4P9
Quebec City, Quebec, Canada, QC G1S 4L8
Quebec City, Quebec, Canada, G1L 3L5
Quebec City, Quebec, Canada, G1R 1S9
Saint-jean Sur Richelieu, Quebec, Canada, J2X 4C7
St-charles Borromee, Quebec, Canada, J6E 2C3
Croatia
Osijek, Croatia, 31000
Pula, Croatia, 52100
Rijeka, Croatia, 51000
Split, Croatia, 21000
Zadar, Croatia, 23000
Zagreb, Croatia, 10000
France
Agen, France, 47002
Aix En Provence, France, 13616
Albi, France, 81000
Amiens, France, 80054
Angers, France, 49033
Annecy, France, 74011
Antibes, France, 06600
Argenteuil, France, 95107
Aubagne, France, 13675
Aulnay Sous Bois, France, 93602
Bastia, France, 20200
Beaumont, France, 63110
Beausoleil, France, 06240
Beauvais, France, 60021
Besancon, France, 25030
Besancon, France, 25000
Beziers, France, 34525
Beziers, France, 34500
Bordeaux, France, 33077
Bordeaux, France, 33000
Boulogne Billancourt, France, 92104
Bourgoin Jallieu, France, 38317
Caen, France, 14033
Challans, France, 85302
Chambery, France, 73011
Clermont Ferrand, France, 63050
Clichy, France, 92118
Colmar, France, 68024
Cornebarrieu, France, 31700
Creil, France, 60109
Creteil, France, 94010
Creteil, France, 94000
Dijon, France, 21079
Dijon, France, 21000
Draguignan, France, 83300
Druex, France, 28102
Evreux, France, 27015
Frejus, France, 83608
Freyming Merlebach, France, 57804
Grasse, France, 06130
Grenoble, France, 38043
Herouville St Clair, France, 14200
Hyeres, France, 83407
La Rochelle, France, 17100
La Valette du Var, France, 83160
Lagny Sur Marne, France, 77405
Le Chesnay, France, 78157
Le Havre, France, 76600
Le Kremlin Bicetre, France, 94275
Le Pradet, France, 83220
Lille, France, 59037
Limoges, France, 87042
Lomme, France, 59462
Lorient, France, 56322
Lyon, France, 69288
Lyon, France, 69317
Lyon, France, 69437
Lyon, France, 69009
Marseille, France, 13002
Marseille, France, 13385
Marseille, France, 13285
Marseille, France, 13015
Marseille, France, 13384
Marseille, France, 13291
Martigues, France, 13500
Meaux, France, 77104
Melun, France, 77011
Menton, France, 06507
Metz, France, 57038
Metz, France, 57003
Monaco, France, 98012
Montauban, France, 82013
Montpellier, France, 34070
Montpellier, France, 34295
Montpellier, France, 34000
Mulhouse, France, 68070
Muret, France, 31605
Nanterre, France, 92000
Nantes, France, 44093
Nantes, France, 44000
Nice, France, 6000
Nice, France, 06000
Nice, France, 06202
Nimes, France, 30029
Nimes, France, 30900
Ollioules, France, 83192
Orange, France, 84106
Orleans, France, 45100
Paris, France, 75970
Paris, France, 75679
Paris, France, 75571
Paris, France, 75877
Paris, France, 75006
Paris, France, 75651
Perigueux, France, 24019
Perpignan, France, 66046
Pessac, France, 33604
Plan de Cuques, France, 13380
Poissy, France, 78303
Poitiers, France, 86021
Pont a Mousson, France, 54700
Reims, France, 51092
Rennes, France, 35033
Roubaix, France, 59056
Rouen, France, 76031
Royan, France, 17201
Saint Laurent Du Var, France, 06721
Sete, France, 34207
St Dizier, France, 52115
St Jean De Verges, France, 09000
St Mande, France, 94163
Ste Maxime, France, 83120
Strasbourg, France, 67091
Tarbes, France, 65000
Toulon, France, 83000
Toulouse, France, 31078
Toulouse, France, 31082
Toulouse, France, 31077
Toulouse, France, 31076
Toulouse, France, 31059
Tourcoing, France, 59208
Valenciennes, France, 59322
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804
Hungary
Ajka, Hungary, H-8400
Bekescsaba, Hungary, 5600
Budapest, Hungary, 1097
Budapest, Hungary, 1083
Budapest, Hungary, 1135
Budapest, Hungary, H-1125
Budapest, Hungary, 1088
Debrecen, Hungary, 4032
Debrecen, Hungary, H-4031
Eger, Hungary, 3300
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3529
Miskolc, Hungary, H-3501
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7623
Szeged, Hungary, 6720
Szekszard, Hungary, 7100
Szolnok, Hungary, 5000
Szombathely, Hungary, 9700
Székesfehérvár, Hungary, 8000
Tatabánya, Hungary, 2800
Zalaegerszeg, Hungary, 8901
Zalaegerszeg, Hungary, 8900
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Mexico
Chihuahua, Mexico, 31170
Chihuahua, Mexico, 31000
Culiacan, Mexico, 80230
Estado de Mexico, Mexico, 54700
Guadalajara, Mexico, 45100
Guadalajara, Mexico, 44650
Hermosillo, Mexico, 83150
Maztlan, Mexico, 82112
Mexicali, Mexico, 21000
Mexico City, Mexico, 14050
Mexico DF, Mexico, 11649
Monterrey, Mexico, 64710
Puebla, Mexico, 72550
Puebla, Mexico, 72560
Tijuana, Mexico, 22000
Tijuana, Mexico, 22195
Morocco
Casablanca, Morocco, 20100
Casablanca, Morocco, 20000
Rabat, Morocco, 504
Poland
Bydgoszcz, Poland, 85-030
Lodz, Poland, 91-347
Warszawa, Poland, 02-507
Warszawa, Poland, 01-201
Wroclaw, Poland, 51-124
Romania
Arad, Romania, 310037
Brasov, Romania, 500174
Brasov, Romania, 500326
Brasov, Romania, 500007
Bucharest, Romania, 21105
Bucharest, Romania, 005098
Bucharest, Romania, 022328
Bucharest, Romania, 030303
Bucharest, Romania, 010825
Bucharest, Romania, 020475
Bucharest, Romania, 021105
Cluj Napoca, Romania, 400015
Cluj-napoca, Romania, 400162
Constanta, Romania, 900900
Constanta, Romania
Constanta, Romania, 8700
Iasi, Romania, 700116
Iasi, Romania, 700111
Sector 2, Romania, 020125
Targu-Mures, Romania, 540136
Timisoara, Romania, 293406
Timisoara, Romania, 300310
Serbia
Belgrade, Serbia, 11000
NIS, Serbia, 18000
Novi Sad, Serbia, 21000
Slovenia
Celje, Slovenia, 3000
Ljubljana, Slovenia, 1000
Maribor, Slovenia, 2000
Murska Sobota, Slovenia, 9101
Novo Mesto, Slovenia, 8000
Sweden
Eskilstuna, Sweden, 63188
Goeteborg, Sweden, 41685
Halmstad, Sweden, S301 85
Huddinge, Sweden, 14186
Linkoeping, Sweden, 58185
Lund, Sweden, 22185
Malmoe, Sweden, 20502
Oerebro, Sweden, 70185
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: NCT01070550     History of Changes
Other Study ID Numbers: MV21012
Study First Received: February 9, 2010
Last Updated: October 13, 2014
Health Authority: Canada: Canadian Institutes of Health Research

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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014