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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01675427
First received: August 24, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 4000
Study Start Date: August 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675427

Contacts
Contact: Please reference Study ID Number: MV25600 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 211 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: May 13, 2013
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 June 18, 2013