Trial Outcomes & Findings for High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1 (NCT NCT00735969)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

24 weeks after treatment stop

Results posted on

2014-10-20

Participant milestones
Measure	Peginterferon and Ribavirin Arm Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and assigned to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Withdrawal data not reported

High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1

Baseline characteristics by cohort
Measure	Peginterferon and Ribavirin Arm n=21 Participants Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
Age, Continuous	55 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

Timeframe: 24 weeks after treatment stop

Outcome measures
Measure	Peginterferon and Ribavirin Arm n=21 Participants Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.	3 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Peginterferon and Ribavirin Arm n=21 participants at risk Patients 18 years of age and older with chronic hepatitis C genotype 1 who have not been successfully treated with a standard course of Peginterferon and ribavirin are screened and randomly assigned to receive either standard treatment with Peginterferon and ribavirin or to receive Peginterferon plus twice the dose of ribavirin (2,000 to 2,400 mg daily) for 48 weeks.
Blood and lymphatic system disorders symptomatic anemia	9.5% 2/21 • Number of events 2

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phone: (301) 402-5115