Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations

NCT01517529 | Completed Results

• 1 other identifier: UC 11101915
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

Conditions

Hepatitis C

Keywords

Hepatitis C; HCV

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed Standard Treatment

  Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.

  9 months

Secondary Outcomes (1)

• Number of Participants Who Cleared the Virus

  9 months

Study Arms (1)

10 Hepatitis C infected subjects

10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.

You may qualify if:

• Male or female
• Age 18 to 65
• Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for \>6 months
• Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.

You may not qualify if:

• Treatment naïve chronically HCV-infected patients.
• Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
• Pregnancy
• HIV

Sponsors & Collaborators

• University of Cincinnati: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17.

  PMID: 26885675 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood lymphocytes from enrolled subjects will be retained until all investigations will be performed and publications are generated. After that remaining samples will be discarded properly according to the Biosafety instructions.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Mohamed Tarek M Shata
• Organization: University of Cincinnati

mohamed.shata@uc.edu

(513) 558-6110

Study Officials

• Mohamed Tarek. M Shata, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: September 30, 2015

Record last verified: 2015-10

Locations

US (1)