An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Global Observational Cohort Study on the Prediction of Unwanted Adverse Effects in Individuals Infected With Chronic Hepatitis C Receiving a Long Acting Interferon Plus Ribavirin

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic

• Study Type: Observational
• Enrollment (Actual): 4459

Contacts and Locations

Study Locations

• Albania
  • Elbasan, Albania
  • Tirana, Albania, 1000
• Algeria
  • Algiers, Algeria, 16000
• Bahrain
  • Bahrain, Bahrain, 28743
  • Manama, Bahrain, 12
• Belgium
  • Antwerpen, Belgium, 2060
  • Antwerpen, Belgium, 2018
  • Brugge, Belgium, 8000
  • Brussel, Belgium, 1090
  • Brussels, Belgium, 1000
  • Bruxelles, Belgium, 1020
  • Bruxelles, Belgium, 1070
  • Bruxelles, Belgium, 1200
  • Bruxelles, Belgium, 1180
  • Bruxelles, Belgium, 1190
  • Charleroi, Belgium, 6000
  • Charleroi, Belgium, B6000
  • Edegem, Belgium, 2650
  • Genk, Belgium, 3600
  • Gent, Belgium, 9000
  • Gerrardsbergen, Belgium, 9500
  • Haine-Saint-Paul, Belgium, 7100
  • Hasselt, Belgium, 3500
  • Kortrijk, Belgium, 8500
  • Leuven, Belgium, 3000
  • Liège, Belgium, 4000
  • Mont-godinne, Belgium, 5530
  • Namur, Belgium, 5000
  • Oostende, Belgium, 8400
  • Roeselare, Belgium, 8800
  • Seraing, Belgium, 4100
  • Sijsele, Belgium, 8340
  • Verviers, Belgium, 4800
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
  • Bihac, Bosnia and Herzegovina, 77000
  • Mostar, Bosnia and Herzegovina, 88000
  • Sarajevo, Bosnia and Herzegovina, 71000
  • Tuzla, Bosnia and Herzegovina, 75000
  • Zenica, Bosnia and Herzegovina, 72000
• Brazil
  • BA
    • Salvador, BA, Brazil, 41110-170
  • MG
    • Belo Horizonte, MG, Brazil, 31270-901
    • Uberaba, MG, Brazil, 38025-180
  • RJ
    • Nova Iguacu, RJ, Brazil, 26030-380
    • Rio de Janeiro, RJ, Brazil, 20020-022
    • Rio de Janeiro, RJ, Brazil, 20270-004
  • SP
    • Botucatu, SP, Brazil, 18600-400
    • Campinas, SP, Brazil, 13026-210
    • Santo Andre, SP, Brazil, 09060-650
    • Santos, SP, Brazil, 11015470
    • Sao Jose do Rio Preto, SP, Brazil, 15090-000
    • Sao Paulo, SP, Brazil, 04040-003
    • Sao Paulo, SP, Brazil, 04040-002
    • Sorocaba, SP, Brazil, 18047-600
• Egypt
  • Alexandria, Egypt
  • Cairo, Egypt
  • Tanta, Egypt
• Greece
  • Alexandroupolis, Greece, 68100
  • Athens, Greece, 115 27
  • Athens, Greece, 11521
  • Athens, Greece, 11527
  • Athens, Greece, 11522
  • Athens, Greece, 11526
  • Athens, Greece, 10676
  • Athens, Greece, 15121
  • Athens, Greece, 10552
  • Athens, Greece, 14233
  • Ioannina, Greece, 455 00
  • Patra, Greece, 265 04
  • Piraeus, Greece, 18536
  • Piraeus, Greece, 18454
  • Rhodes, Greece, 85100
  • Thessaloniki, Greece, 546 42
• Hungary
  • Ajka, Hungary, H-8400
  • Balassagyarmat, Hungary, 2660
  • Bekescsaba, Hungary, 5600
  • Budapest, Hungary, 1083
  • Budapest, Hungary, 1088
  • Budapest, Hungary, 1097
  • Budapest, Hungary, H-1125
  • Budapest, Hungary, 1067
  • Debrecen, Hungary, 4032
  • Debrecen, Hungary, H-4031
  • Gyor, Hungary, 9024
  • Gyula, Hungary, 5700
  • Kaposvár, Hungary, 7400
  • Kecskemet, Hungary, 6000
  • Miskolc, Hungary, 3529
  • Miskolc, Hungary, H-3501
  • Mosonmagyaróvár, Hungary, 9200
  • Nyíregyháza, Hungary, 4400
  • Pecs, Hungary, 7623
  • Sopron, Hungary, 9400
  • Szeged, Hungary, 6720
  • Szolnok, Hungary, 5000
  • Szombathely, Hungary, 9700
  • Székesfehérvár, Hungary, 8000
  • Tatabánya, Hungary, 2800
  • Zalaegerszeg, Hungary, 8900
  • Zalaegerszeg, Hungary, 8901
• India
  • Cochin, India, 682017
  • Hyderabad, India, 500082
  • Lucknow, India, 226010
  • Ludhiana, India, 141 001
  • Mizoram, India
  • Mumbai, India, 400025
  • Mumbai, India, 400053
  • Noida, India, 201 301
  • Maharashtra
    • Pune, Maharashtra, India, 411001
• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 14117
• Italy
  • Abruzzo
    • Pescara, Abruzzo, Italy, 65100
    • Pescara, Abruzzo, Italy, 65124
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
    • Reggio Calabria, Calabria, Italy, 89100
  • Campania
    • Avellino, Campania, Italy, 83100
    • Benevento, Campania, Italy, 82100
    • Gragnano, Campania, Italy, 80054
    • Napoli, Campania, Italy, 80131
    • Napoli, Campania, Italy, 80138
    • Napoli, Campania, Italy, 80136
    • Napoli, Campania, Italy, 80123
    • Salerno, Campania, Italy, 84123
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
    • Carpi, Emilia-Romagna, Italy, 41012
    • Modena, Emilia-Romagna, Italy, 41100
    • Parma, Emilia-Romagna, Italy, 43100
    • Ravenna, Emilia-Romagna, Italy, 48100
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
  • Lazio
    • Frosinone, Lazio, Italy, 03100
    • Gaeta, Lazio, Italy, 04024
    • Roma, Lazio, Italy, 00168
    • Roma, Lazio, Italy, 00161
    • Roma, Lazio, Italy, 00149
    • Roma, Lazio, Italy, 00045
  • Liguria
    • Genova, Liguria, Italy, 16132
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
    • Brescia, Lombardia, Italy, 25125
    • Busto Arsizio, Lombardia, Italy, 21052
    • Como, Lombardia, Italy, 22100
    • Milano, Lombardia, Italy, 20132
    • Milano, Lombardia, Italy, 20157
    • Milano, Lombardia, Italy, 20122
    • Milano, Lombardia, Italy, 20162
    • Milano, Lombardia, Italy, 20142
    • Milano, Lombardia, Italy, 20121
    • Treviglio, Lombardia, Italy, 24047
  • Marche
    • Torrette Di Ancona, Marche, Italy, 60020
  • Molise
    • Campobasso, Molise, Italy, 86100
  • Piemonte
    • Asti, Piemonte, Italy, 14100
    • Biella, Piemonte, Italy, 13900
    • Novara, Piemonte, Italy, 28100
    • Omegna (VB), Piemonte, Italy, 28887
    • Orbassano, Piemonte, Italy, 10043
    • Torino, Piemonte, Italy, 10126
    • Torino, Piemonte, Italy, 10149
  • Puglia
    • Brindisi, Puglia, Italy, 72100
    • Foggia, Puglia, Italy, 71100
    • Galatina, Puglia, Italy, 73013
    • San Giovanni Rotondo, Puglia, Italy, 71013
  • Sardegna
    • Cagliari, Sardegna, Italy, 09042
    • Cagliari, Sardegna, Italy, 09100
    • Sassari, Sardegna, Italy, 07100
  • Sicilia
    • Catania, Sicilia, Italy, 95126
    • Comiso, Sicilia, Italy, 97013
    • Messina, Sicilia, Italy, 98124
    • Palermo, Sicilia, Italy, 90127
  • Toscana
    • Firenze, Toscana, Italy, 50134
    • Pisa, Toscana, Italy, 56124
  • Umbria
    • Perugia, Umbria, Italy, 06123
  • Veneto
    • Padova, Veneto, Italy, 35128
    • Rovigo, Veneto, Italy, 45100
• Korea, Republic of
  • Buchun, Korea, Republic of, 420-021
  • Busan, Korea, Republic of, 602-715
  • Seoul, Korea, Republic of, 03080
  • Seoul, Korea, Republic of, 120-752
  • Seoul, Korea, Republic of, 135-710
  • Suwon, Korea, Republic of, 442-723
• Kuwait
  • Hawali, Kuwait, 32052
  • Safat, Kuwait, 4077
  • Safat, Kuwait, 4710
• Lebanon
  • Baabda, Lebanon, 50
  • Beirut, Lebanon, 99999
  • Beirut, Lebanon, 11-236
  • Beirut, Lebanon
  • Saida, Lebanon
  • Tripoli, Lebanon, 371 Tripoli
• Macedonia, The Former Yugoslav Republic of
  • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
• Morocco
  • Casablanca, Morocco, 20100
  • Casablanca, Morocco, 20000
  • Rabat, Morocco, 504
  • Rabat, Morocco, 62000
• Pakistan
  • Faisalabad, Pakistan
  • Hyderabad, Pakistan, 71000
  • Karachi, Pakistan
  • Lahore, Pakistan
  • Rawalpindi, Pakistan
• Poland
  • Bialystok, Poland, 15-540
  • Bydgoszcz, Poland, 85-030
  • Bytom, Poland, 41-902
  • Chorzow, Poland, 41-500
  • Cieszyn, Poland, 43-400
  • Gdansk, Poland, 80-214
  • Katowice, Poland, 40-752
  • Krakow, Poland, 31-202
  • Krakow, Poland, 30-901
  • Lancut, Poland, 37-100
  • Lodz, Poland, 91-347
  • Pulawy, Poland, 24-100
  • Raciborz, Poland, 47-400
  • Tychy, Poland, 43-100
  • Walbrzych, Poland, 58-300
  • Warszawa, Poland, 01-201
  • Warszawa, Poland, 02-507
  • Wroclaw, Poland, 51-124
  • Łodz, Poland, 91-347
• Portugal
  • Almada, Portugal, 2805-267
  • Amadora, Portugal, 2700-020
  • Aveiro, Portugal, 3810-096
  • Beja, Portugal, 7801-849
  • Beja, Portugal, 7800-309
  • Coimbra, Portugal, 3041-801
  • Faro, Portugal, 8000-386
  • Lisboa, Portugal, 1649-035
  • Lisboa, Portugal, 1349-019
  • Lisboa, Portugal, 1069-639
  • Porto, Portugal, 4202-451
  • Porto, Portugal, 4369-004
  • Santarém, Portugal, 2005-177
  • Vila Real, Portugal, 5000-508
• Qatar
  • Doha, Qatar, P.O.Box 3051
• Romania
  • Brasov, Romania, 500326
  • Brasov, Romania, 500007
  • Brasov, Romania, 500174
  • Bucharest, Romania, 021105
  • Bucharest, Romania, 022328
  • Bucharest, Romania, 010825
  • Bucharest, Romania, 030303
  • Bucharest, Romania, 020475
  • Bucharest, Romania, 005098
  • Cluj Napoca, Romania, 400015
  • Cluj-napoca, Romania, 400162
  • Constanta, Romania, 900900
  • Craiova, Romania, 200515
  • Iasi, Romania, 700111
  • Iasi, Romania, 700116
  • Timisoara, Romania, 293406
• Serbia
  • Belgrade, Serbia, 11000
  • Kragujevac, Serbia, 34000
  • NIS, Serbia, 18000
  • Novi Sad, Serbia, 21000
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
  • Bratislava, Slovakia, 811 07
  • Bratislava, Slovakia, 833 03
  • Bratislava, Slovakia, 833 05
  • Kosice, Slovakia, 04001
  • Kosice, Slovakia, 040 01
  • Martin, Slovakia, 036 59
  • Presov, Slovakia, 080 01
  • Trencin, Slovakia, 911 71
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 51900
  • Dubai, United Arab Emirates, 4545

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin

Description

Inclusion Criteria:

• Adult patients (according to local legislation)
• Chronic hepatitis C
• Treatment with long-acting interferon plus ribavirin
• Quantifiable HCV RNA before initiation of treatment
• No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

Exclusion Criteria:

• End stage renal disease
• Major organ transplantation
• Concomitant therapy with telbivudine
• Pregnant or breast-feeding females
• Male partners of pregnant females

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin	4 years
Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment)	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	4 years
Correlation of on-treatment factors and dose reduction/treatment discontinuation	4 years
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR	4 years
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients	4 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Foster GR, Coppola C, Derbala M, Ferenci P, Orlandini A, Reddy KR, Tallarico L, Shiffman ML, Ahlers S, Bakalos G, Hassanein T; GUARD-C Study Group. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort. PLoS One. 2016 Mar 28;11(3):e0151703. doi: 10.1371/journal.pone.0151703. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: MV22255