Trial Outcomes & Findings for Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection (NCT NCT01182298)

Last Updated: 2019-09-24

Results Overview

The primary end point of this study is the the log change in HCV RNA levels on Day 7

Recruitment status

TERMINATED

Target enrollment

10 participants

Primary outcome timeframe

first 7 days

Results posted on

2019-09-24

Participant milestones
Measure	PegIFN and Ribavirin Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin. This is an observational study. The observed treatment is received and managed through their primary care.
Overall Study STARTED	10
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	PegIFN and Ribavirin Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin. This is an observational study. The observed treatment is received and managed through their primary care.
Overall Study Lack of Efficacy	4
Overall Study Withdrawal by Subject	2

Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection

Baseline characteristics by cohort
Measure	Standard n=10 Participants HCV INFECTED LATINO ARTICIPANTS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Puerto Rico	10 participants n=5 Participants

Timeframe: first 7 days

The primary end point of this study is the the log change in HCV RNA levels on Day 7

Outcome measures
Measure	Hepatitis C n=10 Participants latino participants with Hepatitis C
Median Log Change in HCV RNA Levels on Day 7	NA log IU/mL Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Numbers are insufficient to generate results.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

NIAID