Clinical trial NCT01675427: 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
Official title: An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 4766
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive
timeFrame: Study Visit 1 (single study visit)
measure: Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
Secondary outcomes:
measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive
timeFrame: Study Visit 1
measure: BMI by IL28B Genotype rs12979860: Treatment-Experienced
timeFrame: Study Visit 1
measure: BMI by IL28B Genotype rs8099917: Treatment-Naive
timeFrame: Study Visit 1
measure: BMI by IL28B Genotype rs8099917: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive
timeFrame: Study Visit 1
measure: Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
measure: Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype
timeFrame: Study Visit 1
Other outcomes:
Locations:
city: Alexandria
country: United States
state: Virginia
city: Buenos Aires
country: Argentina
city: Mar del Plata
country: Argentina
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Heusy
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Oostende
country: Belgium
city: Roeselare
country: Belgium
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Cairo
country: Egypt
city: Cairo
country: Egypt
city: Giza
country: Egypt
city: Menoufiya
country: Egypt
city: Tanta
country: Egypt
city: Kohtla-Järve
country: Estonia
city: Pärnu
country: Estonia
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Avignon
country: France
city: Chateauroux
country: France
city: Creteil
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Burghausen
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt an der Oder
country: Germany
city: Kassel
country: Germany
city: Köln
country: Germany
city: Lübeck
country: Germany
city: Magdeburg
country: Germany
city: Mannheim
country: Germany
city: Rostock
country: Germany
city: Rottenburg
country: Germany
city: Tübingen
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Ioannina
country: Greece
city: Larissa
country: Greece
city: Nea Kifissia
country: Greece
city: Patra
country: Greece
city: Thessaloniki
country: Greece
city: Chieti
country: Italy
state: Abruzzo
city: Reggio Calabria
country: Italy
state: Calabria
city: Avellino
country: Italy
state: Campania
city: Gragnano
country: Italy
state: Campania
city: Marcianise
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Nocera Inferiore
country: Italy
state: Campania
city: Nola
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Savona
country: Italy
state: Liguria
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torrette Di Ancona
country: Italy
state: Marche
city: Biella
country: Italy
state: Piemonte
city: Cuorgnè (TO)
country: Italy
state: Piemonte
city: Omegna (VB)
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Bisceglie
country: Italy
state: Puglia
city: Castellana Grotte
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Catania
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Arezzo
country: Italy
state: Toscana
city: Firenze
country: Italy
state: Toscana
city: Livorno
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Safat
country: Kuwait
city: Riga
country: Latvia
city: Baabda
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Beirut
country: Lebanon
city: Nabatieh
country: Lebanon
city: Tripoli
country: Lebanon
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Panevezys
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Culiacan
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Tijuana
country: Mexico
city: Muscat
country: Oman
city: Faisalabad
country: Pakistan
city: Gujranwala
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Lahore
country: Pakistan
city: Rawalpindi
country: Pakistan
city: La Victoria, Lima
country: Peru
city: Lima
country: Peru
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Aveiro
country: Portugal
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Doha
country: Qatar
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Timisoara
country: Romania
city: Belgrade
country: Serbia
city: Novi Sad
country: Serbia
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Martin
country: Slovakia
city: Presov
country: Slovakia
city: Gävle
country: Sweden
city: Karlstad
country: Sweden
city: Uppsala
country: Sweden
city: Lugano
country: Switzerland
city: St. Gallen
country: Switzerland
city: Aleppo
country: Syrian Arab Republic
city: Kaohsiung
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Adana
country: Turkey
city: Adapazari
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Eskisehir
country: Turkey
city: Hatay
country: Turkey
city: ISTANBULt
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Mersin
country: Turkey
city: Samsun
country: Turkey
city: Tokat
country: Turkey
city: Trabzon
country: Turkey
city: Zonguldak
country: Turkey
city: Dubai
country: United Arab Emirates
city: Sharjah
country: United Arab Emirates
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
city: Caracas
country: Venezuela
city: Maracaibo
country: Venezuela
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: