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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01675427
Date of registration:	24/08/2012
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	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
Scientific title:	An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C
Date of first enrolment:	August 2011
Target sample size:	4766
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01675427
Study type:	Interventional
Study design:
Phase:	Phase 4

Countries of recruitment
Argentina	Belgium	Chile	Egypt	Estonia	France	Germany	Greece
Italy	Kuwait	Latvia	Lebanon	Lithuania	Macedonia, The Former Yugoslav Republic of	Mexico	Oman
Pakistan	Peru	Portugal	Qatar	Romania	Serbia	Slovakia	Sweden
Switzerland	Syrian Arab Republic	Taiwan	Turkey	United Arab Emirates	United States	Venezuela

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Intervention(s)

Other: Interleukin 28B testing

Primary Outcome(s)

Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive [Time Frame: Study Visit 1 (single study visit)]

Secondary Outcome(s)

Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive [Time Frame: Study Visit 1]

Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive [Time Frame: Study Visit 1]

Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive [Time Frame: Study Visit 1]

Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced [Time Frame: Study Visit 1]

BMI by IL28B Genotype rs8099917: Treatment-Naive [Time Frame: Study Visit 1]

Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

BMI by IL28B Genotype rs8099917: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive [Time Frame: Study Visit 1]

Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

BMI by IL28B Genotype rs12979860: Treatment-Experienced [Time Frame: Study Visit 1]

Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced [Time Frame: Study Visit 1]

Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]) [Time Frame: Study Visit 1]

Secondary ID(s)

MV25600

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	08/06/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01675427

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