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

NCT01066793 | Completed Results

• 1 other identifier: MV21020
• Study Type: observational
• Target: 2,343
• Locations: 4 countries
• Sites: 100

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) 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Sustained Virological Response by Type of Peginterferon and 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 HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. 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 Type of Peginterferon and 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 and PEG-IFN alfa-2b. 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 Type of Peginterferon and 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 population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. 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 Type of Peginterferon and 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 and PEG-IFN alfa-2b. 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 on Modified Sustained Virological Response 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 and PEG-IFN alfa-2b. 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 on Modified Sustained Virological Response 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 and PEG-IFN alfa-2b. 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 Type of Peginterferon and 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 Virological Response by Type of Peginterferon and 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 Type of Peginterferon and 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 Over Time by Type of Peginterferon and 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 a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12

  At Week 2, Week 4 and Week 12

Study Arms (1)

Cohort

Participants chronically infected with the hepatitis C virus including genotypes 1 to 6

Drug: Peginterferon alfa-2a [Pegasys]; Drug: Peginterferon alfa-2b [PegIntron®]

Interventions

Peginterferon alfa-2a [Pegasys] DRUG

Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

Cohort

Peginterferon alfa-2b [PegIntron®] DRUG

Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving peginterferon alfa 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 HBV
• previous treatment with peginterferon and/or ribavirin

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (100)

Unknown Facility

Aalst, 9300, Belgium

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Antwerp, 2018, Belgium

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Antwerp, 2060, Belgium

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Bruges, 8000, Belgium

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Brussels, 1000, Belgium

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Brussels, 1020, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Brussels, 1190, Belgium

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Brussels, 1200, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Gilly (Charleroi), 6060, Belgium

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Godinne, 5530, Belgium

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Haine-Saint-Paul, 7100, Belgium

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Namur, 5000, Belgium

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Ostend, 8400, Belgium

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Roeselare, 8800, Belgium

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Seraing, 4100, Belgium

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Sijsele, 8340, Belgium

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Tielt, 8880, Belgium

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Verviers, 4800, Belgium

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Dublin, 4, Ireland

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Dublin, 8, Ireland

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Dublin, 9, Ireland

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Pescara, Abruzzo, 65124, Italy

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Bisceglie, Apulia, 70052, Italy

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Brindisi, Apulia, 72100, Italy

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Casarano, Apulia, 73042, Italy

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Castellana Grotte, Apulia, 70013, Italy

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Foggia, Apulia, 71100, Italy

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Galatina, Apulia, 73013, Italy

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Taranto, Apulia, 74100, Italy

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Catanzaro, Calabria, 88100, Italy

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Vibo Valentia, Calabria, 89900, Italy

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Barra, Campania, 80147, Italy

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Benevento, Campania, 82100, Italy

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Gragnano, Campania, 80054, Italy

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Napoli, Campania, 80123, Italy

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Napoli, Campania, 80131, Italy

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Napoli, Campania, 80136, Italy

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Napoli, Campania, 80137, Italy

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Napoli, Campania, 80138, Italy

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Napoli, Campania, 80141, Italy

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Napoli, Campania, 80143, Italy

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Nola, Campania, 80035, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Ferrara, Emilia-Romagna, 44100, Italy

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Parma, Emilia-Romagna, 43100, Italy

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Basovizza (TS), Friuli Venezia Giulia, 34100, Italy

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Udine, Friuli Venezia Giulia, 33100, Italy

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Rome, Lazio, 00128, Italy

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Rome, Lazio, 00133, Italy

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Rome, Lazio, 00149, Italy

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Rome, Lazio, 00152, Italy

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Rome, Lazio, 00161, Italy

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Rome, Lazio, 00165, Italy

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Rome, Lazio, 00168, Italy

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Savona, Liguria, 17100, Italy

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Brescia, Lombardy, 25125, Italy

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Busto Arsizio, Lombardy, 21052, Italy

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Cremona, Lombardy, 26100, Italy

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Lecco, Lombardy, 23900, Italy

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Milan, Lombardy, 20121, Italy

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Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20142, Italy

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Milan, Lombardy, 20153, Italy

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Monza, Lombardy, 20052, Italy

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Saronno, Lombardy, 21047, Italy

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Treviglio, Lombardy, 24047, Italy

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Isernia, Molise, 86170, Italy

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Alessandria, Piedmont, 15100, Italy

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Asti, Piedmont, 14100, Italy

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Biella, Piedmont, 13900, Italy

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Novara, Piedmont, 28100, Italy

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Turin, Piedmont, 10126, Italy

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Turin, Piedmont, 10128, Italy

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Cagliari, Sardinia, 09042, Italy

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Catania, Sicily, 95126, Italy

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Comiso, Sicily, 97013, Italy

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Palermo, Sicily, 90127, Italy

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Fermo, The Marches, 63023, Italy

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Bolzano, Trentino-Alto Adige, 39100, Italy

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Trento, Trentino-Alto Adige, 38100, Italy

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Arezzo, Tuscany, 52100, Italy

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Florence, Tuscany, 50134, Italy

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Grosseto, Tuscany, 58100, Italy

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Perugia, Umbria, 06123, Italy

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Mestre (VE), Veneto, 30172, Italy

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Padua, Veneto, 35128, Italy

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Treviso, Veneto, 31100, Italy

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Venezia, Veneto, 30122, Italy

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Verona, Veneto, 37134, Italy

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London, NW3 2QG, United Kingdom

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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: 26158171 DERIVED

• 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.

  PMID: 24329937 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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 10, 2010
• Study Start: October 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 9, 2016
• Results First Posted: May 9, 2016

Record last verified: 2016-04

Locations

BE (27); IT (69); IE (3); GB (1)