A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C
An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C
1 other identifier
interventional
4,766
30 countries
208
Brief Summary
This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
Typical duration for phase_4
208 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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedAugust 26, 2015
August 1, 2015
2.2 years
August 24, 2012
May 21, 2015
August 12, 2015
Conditions
Outcome Measures
Primary Outcomes (16)
Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 \[G1\], Genotype 2 \[G2\], Genotype 3 \[G3\], Genotype 4 \[G4\], and all other genotypes \[Other\]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.
Study Visit 1 (single study visit)
Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.
Study Visit 1
Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).
Study Visit 1
Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.
Study Visit 1
Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.
Study Visit 1
Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.
Study Visit 1
Secondary Outcomes (78)
Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive
Study Visit 1
Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced
Study Visit 1
Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive
Study Visit 1
- +73 more secondary outcomes
Study Arms (1)
Chronic hepatitis C patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based therapy for CHC for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required
You may not qualify if:
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including liver transplantation)
- End stage renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (210)
Unknown Facility
Alexandria, Virginia, 22304, United States
Unknown Facility
Buenos Aires, CP B1704 ETD, Argentina
Unknown Facility
Mar del Plata, 7600, Argentina
Unknown Facility
Antwerp, 2060, Belgium
Unknown Facility
Bruges, 8000, Belgium
Unknown Facility
Brussels, 1000, Belgium
Unknown Facility
Brussels, 1020, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Brussels, 1180, Belgium
Unknown Facility
Brussels, 1190, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Genk, 3600, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Hasselt, 3500, Belgium
Unknown Facility
Heusy, 4802, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Ostend, 8400, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Santiago, 8330024, Chile
Unknown Facility
Santiago, 8380456, Chile
Unknown Facility
Cairo, 11559, Egypt
Unknown Facility
Cairo, Egypt
Unknown Facility
Giza, Egypt
Unknown Facility
Menoufiya, 32511, Egypt
Unknown Facility
Tanta, Egypt
Unknown Facility
Kohtla-Järve, 31025, Estonia
Unknown Facility
Pärnu, 80010, Estonia
Unknown Facility
Tallinn, 10138, Estonia
Unknown Facility
Tallinn, 10617, Estonia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
Avignon, 84902, France
Unknown Facility
Châteauroux, 36019, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Lyon, 69317, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 76031, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Aachen, 52074, Germany
Unknown Facility
Berlin, 10243, Germany
Unknown Facility
Berlin, 10777, Germany
Unknown Facility
Burghausen, 84489, Germany
Unknown Facility
Cologne, 50937, Germany
Unknown Facility
Düsseldorf, 40237, Germany
Unknown Facility
Erlangen, 91054, Germany
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Frankfurt (Oder), 15236, Germany
Unknown Facility
Kassel, 34117, Germany
Unknown Facility
Lübeck, 23562, Germany
Unknown Facility
Magdeburg, 39120, Germany
Unknown Facility
Mannheim, 68167, Germany
Unknown Facility
Rostock, 18057, Germany
Unknown Facility
Rottenburg, 72108, Germany
Unknown Facility
Tübingen, 72076, Germany
Unknown Facility
Alexandroupoli, 68100, Greece
Unknown Facility
Athens, 115 27, Greece
Unknown Facility
Athens, 11522, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Ioannina, 455 00, Greece
Unknown Facility
Larissa, 41 110, Greece
Unknown Facility
Nea Kifissia, 14564, Greece
Unknown Facility
Pátrai, 265 04, Greece
Unknown Facility
Thessaloniki, 546 42, Greece
Unknown Facility
Chieti, Abruzzo, 66013, Italy
Unknown Facility
Bari, Apulia, 70124, Italy
Unknown Facility
Bisceglie, Apulia, 70052, Italy
Unknown Facility
Castellana Grotte, Apulia, 70013, Italy
Unknown Facility
San Giovanni Rotondo, Apulia, 71013, Italy
Unknown Facility
Reggio Calabria, Calabria, 89100, Italy
Unknown Facility
Avellino, Campania, 83100, Italy
Unknown Facility
Gragnano, Campania, 80054, Italy
Unknown Facility
Marcianise, Campania, 81025, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Napoli, Campania, 80136, Italy
Unknown Facility
Napoli, Campania, 80138, Italy
Unknown Facility
Nocera Inferiore, Campania, 84014, Italy
Unknown Facility
Nola, Campania, 80035, Italy
Unknown Facility
Bologna, Emilia-Romagna, 40138, Italy
Unknown Facility
Modena, Emilia-Romagna, 41100, Italy
Unknown Facility
Parma, Emilia-Romagna, 43126, Italy
Unknown Facility
Piacenza, Emilia-Romagna, 29121, Italy
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Rome, Lazio, 00149, Italy
Unknown Facility
Rome, Lazio, 00152, Italy
Unknown Facility
Rome, Lazio, 00161, Italy
Unknown Facility
Rome, Lazio, 00165, Italy
Unknown Facility
Rome, Lazio, 00189, Italy
Unknown Facility
Genoa, Liguria, 16132, Italy
Unknown Facility
Savona, Liguria, 17100, Italy
Unknown Facility
Milan, Lombardy, 20122, Italy
Unknown Facility
Milan, Lombardy, 20123, Italy
Unknown Facility
Milan, Lombardy, 20132, Italy
Unknown Facility
Milan, Lombardy, 20142, Italy
Unknown Facility
Milan, Lombardy, 20157, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Biella, Piedmont, 13900, Italy
Unknown Facility
Cuorgnè (TO), Piedmont, 10082, Italy
Unknown Facility
Omegna (VB), Piedmont, 28887, Italy
Unknown Facility
Cagliari, Sardinia, 09042, Italy
Unknown Facility
Cagliari, Sardinia, 09100, Italy
Unknown Facility
Sassari, Sardinia, 07100, Italy
Unknown Facility
Catania, Sicily, 95100, Italy
Unknown Facility
Catania, Sicily, 95126, Italy
Unknown Facility
Messina, Sicily, 98124, Italy
Unknown Facility
Palermo, Sicily, 90127, Italy
Unknown Facility
Torrette Di Ancona, The Marches, 60020, Italy
Unknown Facility
Arezzo, Tuscany, 52100, Italy
Unknown Facility
Florence, Tuscany, 50134, Italy
Unknown Facility
Livorno, Tuscany, 57124, Italy
Unknown Facility
Padua, Veneto, 35128, Italy
Unknown Facility
Safat, 4077, Kuwait
Unknown Facility
Riga, 1006, Latvia
Unknown Facility
Baabda, 50, Lebanon
Unknown Facility
Beirut, 11-236, Lebanon
Unknown Facility
Beirut, 99999, Lebanon
Unknown Facility
Beirut, Lebanon
Unknown Facility
Nabatieh, Lebanon
Unknown Facility
Tripoli, 371 Tripoli, Lebanon
Unknown Facility
Kaunas, 47116, Lithuania
Unknown Facility
Kaunas, 50009, Lithuania
Unknown Facility
Klaipėda, 92288, Lithuania
Unknown Facility
Panevezys, 35144, Lithuania
Unknown Facility
Šiauliai, 76231, Lithuania
Unknown Facility
Vilnius, 08117, Lithuania
Unknown Facility
Vilnius, 08661, Lithuania
Unknown Facility
Culiacán, 80220, Mexico
Unknown Facility
Mexico City, 02990, Mexico
Unknown Facility
Mexico City, 14050, Mexico
Unknown Facility
Tijuana, 22450, Mexico
Unknown Facility
Skopje, 1000, North Macedonia
Unknown Facility
Muscat, P.O Box 35, Oman
Unknown Facility
Faisalabad, Pakistan
Unknown Facility
Gujranwala, Pakistan
Unknown Facility
Karachi, Pakistan
Unknown Facility
Lahore, 20021, Pakistan
Unknown Facility
Lahore, Pakistan
Unknown Facility
Rawalpindi, Pakistan
Unknown Facility
La Victoria, Lima, Lima 13, Peru
Unknown Facility
Lima, 11, Peru
Unknown Facility
Almada, 2805-267, Portugal
Unknown Facility
Amadora, 2700-020, Portugal
Unknown Facility
Aveiro, 3810-096, Portugal
Unknown Facility
Faro, 8000-386, Portugal
Unknown Facility
Lisbon, 1349-019, Portugal
Unknown Facility
Lisbon, 1649-035, Portugal
Unknown Facility
Porto, 4099-001, Portugal
Unknown Facility
Porto, 4202-451, Portugal
Unknown Facility
Doha, P.O.Box 3051, Qatar
Unknown Facility
Bucharest, 021105, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Cluj-Napoca, 400162, Romania
Unknown Facility
Constanța, Romania
Unknown Facility
Iași, 700554, Romania
Unknown Facility
Iași, 700620, Romania
Unknown Facility
Timișoara, 293406, Romania
Unknown Facility
Timișoara, 300167, Romania
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Novi Sad, 21000, Serbia
Unknown Facility
Banská Bystrica, 975 17, Slovakia
Unknown Facility
Bratislava, 811 07, Slovakia
Unknown Facility
Bratislava, 833 03, Slovakia
Unknown Facility
Bratislava, 833 05, Slovakia
Unknown Facility
Martin, 036 59, Slovakia
Unknown Facility
Prešov, 080 01, Slovakia
Unknown Facility
Gävle, 80187, Sweden
Unknown Facility
Karlstad, 65185, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Lugano, 6900, Switzerland
Unknown Facility
Sankt Gallen, 9007, Switzerland
Unknown Facility
Aleppo, 6448, Syria
Unknown Facility
Kaohsiung City, 00833, Taiwan
Unknown Facility
Kaohsiung City, 807, Taiwan
Unknown Facility
Taichung, 40447, Taiwan
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, 112, Taiwan
Unknown Facility
Taoyuan District, 333, Taiwan
Unknown Facility
Adana, 01100, Turkey (Türkiye)
Unknown Facility
Adapazarı, Turkey (Türkiye)
Unknown Facility
Ankara, 06100, Turkey (Türkiye)
Unknown Facility
Ankara, 06290, Turkey (Türkiye)
Unknown Facility
Ankara, 06800, Turkey (Türkiye)
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Eskişehir, 26480, Turkey (Türkiye)
Unknown Facility
Hatay, 31040, Turkey (Türkiye)
Unknown Facility
Istanbul, 34390, Turkey (Türkiye)
Unknown Facility
ISTANBULt, Turkey (Türkiye)
Unknown Facility
Izmir, 35100, Turkey (Türkiye)
Unknown Facility
Kayseri, 38039, Turkey (Türkiye)
Unknown Facility
Mersin, 33169, Turkey (Türkiye)
Unknown Facility
Samsun, 55139, Turkey (Türkiye)
Unknown Facility
Tokat Province, 60250, Turkey (Türkiye)
Unknown Facility
Trabzon, 61080, Turkey (Türkiye)
Unknown Facility
Zonguldak, Turkey (Türkiye)
Unknown Facility
Dubai, 4545, United Arab Emirates
Unknown Facility
Sharjah city, P.O.Box: 5735 - Sharjah, UAE, United Arab Emirates
Unknown Facility
Caracas, 1010, Venezuela
Unknown Facility
Caracas, 1060, Venezuela
Unknown Facility
Caracas, 1073, Venezuela
Unknown Facility
Caracas, 1080, Venezuela
Unknown Facility
Maracaibo, 4005, Venezuela
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
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
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2012
First Posted
August 30, 2012
Study Start
August 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
August 26, 2015
Results First Posted
June 8, 2015
Record last verified: 2015-08