PROPHESYS 1: An Observational Study on Predictors of Response in Treatment-naïve Patients With Chronic Hepatitis C Virus (HCV)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.
1 other identifier
observational
4,680
13 countries
263
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Longer than P75 for all trials
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
June 15, 2016
CompletedJune 15, 2016
May 1, 2016
4.1 years
February 9, 2010
May 9, 2016
May 9, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population
Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population
Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population
Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population
Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population
The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.
At 24 weeks after EOT
Secondary Outcomes (16)
Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time
At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time
At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time
At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time
At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT
Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12
At Week 2, Week 4, and Week 12
- +11 more secondary outcomes
Study Arms (1)
Cohort
Participants chronically infected with the hepatitis C virus including Genotypes 1 to 6.
Interventions
Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
Eligibility Criteria
Patients receiving peginterferon alfa-2a treatment at a medical centre
You may qualify if:
- adult patients, \>/= 18 years of age
- chronic hepatitis C
- informed consent to data collection
You may not qualify if:
- co-infection with HIV or Hepatitis B Virus (HBV)
- previous treatment with peginterferon and/or ribavirin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (266)
Unknown Facility
Gratwein, 8112, Austria
Unknown Facility
Graz, 8036, Austria
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Linz, 4010, Austria
Unknown Facility
Linz, 4020, Austria
Unknown Facility
Vienna, 1030, Austria
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Vienna, 1100, Austria
Unknown Facility
Vienna, 1160, Austria
Unknown Facility
Salvador, Estado de Bahia, 41110-170, Brazil
Unknown Facility
Goiânia, Goiás, 74535170, Brazil
Unknown Facility
Belo Horizonte, Minas Gerais, 31270-901, Brazil
Unknown Facility
Belém, Pará, 66035-080, Brazil
Unknown Facility
Recife, Pernambuco, 50100-130, Brazil
Unknown Facility
Recife, Pernambuco, 50670-420, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 20270-004, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 20529-900, Brazil
Unknown Facility
Rio de Janeiro, Rio de Janeiro, 22410002, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Unknown Facility
Rio Grande, Rio Grande do Sul, 96200-310, Brazil
Unknown Facility
Botucatu, São Paulo, 18600-400, Brazil
Unknown Facility
Campinas, São Paulo, 13026-210, Brazil
Unknown Facility
Campinas, São Paulo, 13081-970, Brazil
Unknown Facility
Ribeirão Preto, São Paulo, 14085-410, Brazil
Unknown Facility
Santos, São Paulo, 11015470, Brazil
Unknown Facility
São Paulo, São Paulo, 01246-900, Brazil
Unknown Facility
São Paulo, São Paulo, 01246-903, Brazil
Unknown Facility
São Paulo, São Paulo, 04040-002, Brazil
Unknown Facility
São Paulo, São Paulo, 1246-000, Brazil
Unknown Facility
São Paulo, São Paulo, 1323020, Brazil
Unknown Facility
São Paulo, São Paulo, 4029000, Brazil
Unknown Facility
Calgary, Alberta, T2G 0H5, Canada
Unknown Facility
Edmonton, Alberta, T6G 2C8, Canada
Unknown Facility
Kelowna, British Columbia, V1Y 1T2, Canada
Unknown Facility
Nanaimo, British Columbia, V9R 5N9, Canada
Unknown Facility
New Westminster, British Columbia, V3L 3W5, Canada
Unknown Facility
Prince George, British Columbia, V2M 5J6, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 2C7, Canada
Unknown Facility
Victoria, British Columbia, V8R 6R3, Canada
Unknown Facility
Winnipeg, Manitoba, R2W 5L4, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1E 2Z1, Canada
Unknown Facility
Barrie, Ontario, L4M 5G1, Canada
Unknown Facility
Brampton, Ontario, L6S 1C0, Canada
Unknown Facility
Etobicoke, Ontario, M9V 4B8, Canada
Unknown Facility
Greater Sudbury, Ontario, P3E 1B8, Canada
Unknown Facility
Guelph, Ontario, N1E 6Z1, Canada
Unknown Facility
London, Ontario, N6A 5R9, Canada
Unknown Facility
Newmarket, Ontario, L3Y 2P6, Canada
Unknown Facility
North Bay, Ontario, P1B 2H3, Canada
Unknown Facility
Oakville, Ontario, L6J 1X8, Canada
Unknown Facility
Oshawa, Ontario, L1G 2B9, Canada
Unknown Facility
Oshawa, Ontario, L1J 2J9, Canada
Unknown Facility
Ottawa, Ontario, K2B 8E8, Canada
Unknown Facility
Scarborough Village, Ontario, M1T 3V3, Canada
Unknown Facility
Toronto, Ontario, M5A 1L5, Canada
Unknown Facility
Toronto, Ontario, M6A 3B2, Canada
Unknown Facility
Windsor, Ontario, N8X 5A6, Canada
Unknown Facility
Lévis, Quebec, G6V 3Z1, Canada
Unknown Facility
Montreal, Quebec, H2L 4P9, Canada
Unknown Facility
Montreal, Quebec, H2L 5B1, Canada
Unknown Facility
Québec, Quebec, G1L 3L5, Canada
Unknown Facility
Québec, Quebec, G1R 1S9, Canada
Unknown Facility
Québec, Quebec, QC G1S 4L8, Canada
Unknown Facility
Saint-Charles-Borromée, Quebec, J6E 2C3, Canada
Unknown Facility
Saint-Jean-sur-Richelieu, Quebec, J2X 4C7, Canada
Unknown Facility
Osijek, 31000, Croatia
Unknown Facility
Pula, 52000, Croatia
Unknown Facility
Split, 21000, Croatia
Unknown Facility
Zadar, 23000, Croatia
Unknown Facility
Zagreb, 10000, Croatia
Unknown Facility
Agen, 47002, France
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Albi, 81000, France
Unknown Facility
Amiens, 80054, France
Unknown Facility
Angers, 49033, France
Unknown Facility
Annecy, 74000, France
Unknown Facility
Antibes, 06600, France
Unknown Facility
Argenteuil, 95100, France
Unknown Facility
Argenteuil, 95107, France
Unknown Facility
Aulnay-sous-Bois, 93600, France
Unknown Facility
Aulnay-sous-Bois, 93602, France
Unknown Facility
Bastia, 20200, France
Unknown Facility
Beaumont, 63110, France
Unknown Facility
Beausoleil, 06240, France
Unknown Facility
Beauvais, 60021, France
Unknown Facility
Besançon, 25000, France
Unknown Facility
Besançon, 25030, France
Unknown Facility
Béziers, 34500, France
Unknown Facility
Béziers, 34525, France
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Bordeaux, 33300, France
Unknown Facility
Boulogne-Billancourt, 92104, France
Unknown Facility
Bourgoin, 38317, France
Unknown Facility
Caen, 14033, France
Unknown Facility
Chambéry, 73000, France
Unknown Facility
Clermont-Ferrand, 63023, France
Unknown Facility
Clichy, 92118, France
Unknown Facility
Colmar, 68024, France
Unknown Facility
Cornebarrieu, 31700, France
Unknown Facility
Creil, 60100, France
Unknown Facility
Créteil, 94000, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Dijon, 21000, France
Unknown Facility
Dijon, 21079, France
Unknown Facility
Druex, 28107, France
Unknown Facility
Évreux, 27000, France
Unknown Facility
Freyming-Merlebach, 57800, France
Unknown Facility
Fréjus, 83608, France
Unknown Facility
Grasse, 06130, France
Unknown Facility
Grenoble, 38043, France
Unknown Facility
Hérouville-Saint-Clair, 14200, France
Unknown Facility
Hyères, 83400, France
Unknown Facility
La Rochelle, 17100, France
Unknown Facility
La Valette-du-Var, 83160, France
Unknown Facility
Lagny-sur-Marne, 77405, France
Unknown Facility
Le Chesnay, 78157, France
Unknown Facility
Le Havre, 76600, France
Unknown Facility
Le Kremlin-Bicêtre, 94276, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Lomme, 59160, France
Unknown Facility
Lorient, 56322, France
Unknown Facility
Lyon, 69009, France
Unknown Facility
Lyon, 69288, France
Unknown Facility
Lyon, 69437, France
Unknown Facility
Marseille, 13002, France
Unknown Facility
Marseille, 13013, France
Unknown Facility
Marseille, 13015, France
Unknown Facility
Marseille, 13285, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Martigues, 13500, France
Unknown Facility
Meaux, 77104, France
Unknown Facility
Melun, 77011, France
Unknown Facility
Menton, 06507, France
Unknown Facility
Metz, 57038, France
Unknown Facility
Metz, 57045, France
Unknown Facility
Monaco, 98012, France
Unknown Facility
Montauban, 82013, France
Unknown Facility
Montpellier, 34000, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Mulhouse, 68070, France
Unknown Facility
Muret, 31607, France
Unknown Facility
Nanterre, 92000, France
Unknown Facility
Nantes, 44000, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nice, 06000, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Nîmes, 30029, France
Unknown Facility
Nîmes, 30900, France
Unknown Facility
Ollioules, 83190, France
Unknown Facility
Orange, 84100, France
Unknown Facility
Orléans, 45100, France
Unknown Facility
Paris, 75014, France
Unknown Facility
Paris, 75018, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Perpignan, 66046, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Périgueux, 24019, France
Unknown Facility
Poissy, 78303, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Pont-à-Mousson, 54700, France
Unknown Facility
Reims, 51092, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 76031, France
Unknown Facility
Saint-Dizier, 52115, France
Unknown Facility
Saint-Jean-de-Verges, 09000, France
Unknown Facility
Saint-Laurent-du-Var, 06700, France
Unknown Facility
Saint-Mandé, 94163, France
Unknown Facility
Sète, 34207, France
Unknown Facility
Ste Maxime, 83120, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Tarbes, 65951, France
Unknown Facility
Toulon, 83000, France
Unknown Facility
Toulouse, 31054, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Toulouse, 31076, France
Unknown Facility
Toulouse, 31077, France
Unknown Facility
Tourcoing, 59200, France
Unknown Facility
Valenciennes, 59322, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Villejuif, 94804, France
Unknown Facility
Ajka, H-8400, Hungary
Unknown Facility
Békéscsaba, 5600, Hungary
Unknown Facility
Budapest, 1083, Hungary
Unknown Facility
Budapest, 1088, Hungary
Unknown Facility
Budapest, 1097, Hungary
Unknown Facility
Budapest, 1135, Hungary
Unknown Facility
Budapest, H-1125, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Debrecen, H-4031, Hungary
Unknown Facility
Eger, 3300, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Kaposvár, 7400, Hungary
Unknown Facility
Kecskemét, 6000, Hungary
Unknown Facility
Kistarcsa, 2143, Hungary
Unknown Facility
Miskolc, 3529, Hungary
Unknown Facility
Miskolc, H-3501, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Pécs, 7623, Hungary
Unknown Facility
Pécs, 7654, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Szekszárd, 7100, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Szolnok, 5000, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Zalaegerszeg, 8900, Hungary
Unknown Facility
Zalaegerszeg, 8901, Hungary
Unknown Facility
Chihuahua City, 31000, Mexico
Unknown Facility
Chihuahua City, 31170, Mexico
Unknown Facility
Culiacán, 80230, Mexico
Unknown Facility
Guadalajara, 44650, Mexico
Unknown Facility
Hermosillo, 83150, Mexico
Unknown Facility
Mexicali, 21000, Mexico
Unknown Facility
Mexico City, 11649, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Monterrey, 64710, Mexico
Unknown Facility
Puebla City, 72550, Mexico
Unknown Facility
Puebla City, 72560, Mexico
Unknown Facility
Casablanca, 20000, Morocco
Unknown Facility
Casablanca, 20100, Morocco
Unknown Facility
Rabat, 504, Morocco
Unknown Facility
Skopje, 1000, North Macedonia
Unknown Facility
Bydgoszcz, 85-030, Poland
Unknown Facility
Lodz, 91-347, Poland
Unknown Facility
Warsaw, 01-201, Poland
Unknown Facility
Warsaw, 02-507, Poland
Unknown Facility
Wroclaw, 51-124, Poland
Unknown Facility
Arad, 310037, Romania
Unknown Facility
Brasov, 500007, Romania
Unknown Facility
Brasov, 500174, Romania
Unknown Facility
Brasov, 500326, Romania
Unknown Facility
Bucharest, 005098, Romania
Unknown Facility
Bucharest, 010825, Romania
Unknown Facility
Bucharest, 020475, Romania
Unknown Facility
Bucharest, 021105, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Bucharest, 030303, Romania
Unknown Facility
Bucharest, 21105, Romania
Unknown Facility
Cluj-Napoca, 400015, Romania
Unknown Facility
Cluj-Napoca, 400162, Romania
Unknown Facility
Constanța, 8700, Romania
Unknown Facility
Constanța, 900900, Romania
Unknown Facility
Constanța, Romania
Unknown Facility
Iași, 700111, Romania
Unknown Facility
Iași, 700116, Romania
Unknown Facility
Sector 2, 020125, Romania
Unknown Facility
Târgu Mureş, 540136, Romania
Unknown Facility
Timișoara, 293406, Romania
Unknown Facility
Timișoara, 300310, Romania
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Niš, 18000, Serbia
Unknown Facility
Novi Sad, 21000, Serbia
Unknown Facility
Celje, 3000, Slovenia
Unknown Facility
Ljubljana, 1000, Slovenia
Unknown Facility
Maribor, 2000, Slovenia
Unknown Facility
Novo Mesto, 8000, Slovenia
Unknown Facility
Eskilstuna, 63188, Sweden
Unknown Facility
Halmstad, S301 85, Sweden
Unknown Facility
Huddinge, 14186, Sweden
Unknown Facility
Linköping, 58185, Sweden
Unknown Facility
Lund, 22185, Sweden
Unknown Facility
Örebro, 70185, Sweden
Related Publications (2)
Ascione A, Bruno S, Coppola C, Mangia A, Orlandini A, Schmitz M, Deodato B, Puoti M. Treatment Outcomes and Predictors of Response in Treatment-Naive HCV Patients Treated with Peginterferon Alfa/Ribavirin in Real-World Italian Clinics: Sub-Analysis from the PROPHESYS Cohort. Hepatogastroenterology. 2014 Jun;61(132):1094-106.
PMID: 26158171DERIVEDFerenci 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.
PMID: 24329937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 18, 2010
Study Start
June 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 15, 2016
Results First Posted
June 15, 2016
Record last verified: 2016-05