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

November 1, 2016 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4459

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin
Time Frame: 4 years
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)
Time Frame: 4 years
4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 4 years
4 years
Correlation of on-treatment factors and dose reduction/treatment discontinuation
Time Frame: 4 years
4 years
Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR
Time Frame: 4 years
4 years
Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MV22255

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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