Trial Outcomes & Findings for Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations (NCT NCT01517529)

NCT ID: NCT01517529

Last Updated: 2015-11-20

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

9 months

Results posted on

2015-11-20

Participant Flow

We plan to enroll 10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin (RBV) therapy (NR) and are therefore eligible for combined treatment with PI therapy according to the recent FDA approvals for Boceprevir. Patients will be recruited from the outpatient clinics at the University of Cincinnati College of Medicine

Participant milestones

Participant milestones
Measure	10 Hepatitis C Infected Subjects 10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 Hepatitis C Infected Subjects n=10 Participants 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.
Age, Continuous Responders	55.3 years STANDARD_DEVIATION 14.03 • n=93 Participants
Age, Continuous Non responders	60.00 years STANDARD_DEVIATION 5.29 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Measure HCV viral load and HCV-specific immune responses at baseline

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

Outcome measures

Outcome measures
Measure	10 Hepatitis C Infected Subjects n=10 Participants 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.
Number of Participants Who Completed Standard Treatment complete standard treatment	10 participants
Number of Participants Who Completed Standard Treatment not complete	0 participants

SECONDARY outcome

Timeframe: 9 months

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

Outcome measures

Outcome measures
Measure	10 Hepatitis C Infected Subjects n=10 Participants 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.
Number of Participants Who Cleared the Virus responder	7 participants
Number of Participants Who Cleared the Virus Non-responder	3 participants

Adverse Events

10 Hepatitis C Infected Subjects

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	10 Hepatitis C Infected Subjects n=10 participants at risk 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.
Infections and infestations Infection	10.0% 1/10 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohamed Tarek M Shata

University of Cincinnati

Phone: (513) 558-6110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place