N/A N=10

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

Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT01517529 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Sep 2015

Primary outcome: Primary: Number of Participants Who Completed Standard Treatment — 10; 0 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Completed Standard Treatment	10; 0	—
SECONDARY Number of Participants Who Cleared the Virus	7; 3	—

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.

Eligibility Criteria

Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:

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.

Exclusion criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01517529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.