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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01675427
First received: August 24, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and t reatment-experienced chronic hepatitis C patients, including patients with HIV c o-infection. There will be a single study visit for testing.


Condition Intervention Phase
Hepatitis C, Chronic
Other: Interleukin 28B testing
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Correlation of interleukin 28B (IL28B) genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) with liver fibrosis related to CHC [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of IL28B genotypes with liver inflammation related to CHC [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Correlation of IL28B genotypes with demographics in patients with CHC [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Distribution of IL28B genotypes according to CHC genotypes/countries [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Correlation between the IL28B genotypes rs12979860 and rs8099917 in patients with CHC [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Distribution of inosine triphosphatase (ITPA) genotypes in patients with CHC according to CHC genotype/countries [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Correlation between IL28B genotypes and previous treatment outcome in treatment-experienced CHC patients [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Correlation between ITPA genotypes and hemoglobin decline during prior treatment [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Enrollment: 4791
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chronic hepatitis C patients Other: Interleukin 28B testing
Blood sampling for ILB28 genotyping

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675427

  Show 210 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01675427     History of Changes
Other Study ID Numbers: MV25600
Study First Received: August 24, 2012
Last Updated: July 28, 2014
Health Authority: France: Nathional Authority for Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 01, 2014