Trial Outcomes & Findings for Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial (NCT NCT00211692)

NCT ID: NCT00211692

Last Updated: 2014-11-21

Results Overview

Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 64 participants
• Primary outcome timeframe: 24 weeks after the end of treatment
• Results posted on: 2014-11-21

Participant Flow

Patients with difficult-to-treat characteristics (78% VA) were enrolled at 7 Veterans Affairs (VA) and 2 community medical centers.

All eligible patients were randomized and analysis performed using intention to treat.

Participant milestones

Measure	Group A 52 Weeks Treatment Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)	Group B Duration Based on Viral Response CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
Overall Study STARTED	33	31
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial

Baseline characteristics by cohort

Measure	Group A 52 Weeks Treatment n=33 Participants Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)	Group B Duration Based on Viral Response n=31 Participants CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 8.0 • n=5 Participants	49.8 years STANDARD_DEVIATION 8.8 • n=7 Participants	50.6 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after the end of treatment

Population: Convenience sample for pilot trial. Analysis is intention to treat.

Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study

Outcome measures

Measure	A (52 Weeks Treatment) n=33 Participants	B (Duration Based on Viral Response) n=31 Participants
The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response.	11 participants	10 participants

SECONDARY outcome

Timeframe: through end of study up to 72 weeks

Outcome measures

Measure	A (52 Weeks Treatment) n=64 Participants	B (Duration Based on Viral Response)
Number of Participants Discontinuing Early From Study Treatment	26 participants	—

SECONDARY outcome

Timeframe: 24 weeks after end of treatment

Population: participants with analyzable data for this outcome

rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks

Outcome measures

Measure	A (52 Weeks Treatment) n=42 Participants	B (Duration Based on Viral Response)
Participants Achieving SVR Categorized by Time of Response rapid virologic response (n=20)	15 participants	—
Participants Achieving SVR Categorized by Time of Response early virologic response (n=13)	4 participants	—
Participants Achieving SVR Categorized by Time of Response late virologic response (n=9)	2 participants	—

SECONDARY outcome

Timeframe: through end of study up to 72 weeks

Outcome measures

Measure	A (52 Weeks Treatment) n=64 Participants	B (Duration Based on Viral Response)
Overall Number of Serious Adverse Events	2 participants	—

Adverse Events

Overall

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Overall n=64 participants at risk
Nervous system disorders encephalopathy	1.6% 1/64 • Number of events 1 • through end of study up to 72 weeks adverse events were collected for study population as a whole
General disorders chest pain	1.6% 1/64 • Number of events 1 • through end of study up to 72 weeks adverse events were collected for study population as a whole

Other adverse events

Measure	Overall n=64 participants at risk
Nervous system disorders depression/anxiety	6.2% 4/64 • Number of events 4 • through end of study up to 72 weeks adverse events were collected for study population as a whole
Skin and subcutaneous tissue disorders cellulitis	4.7% 3/64 • Number of events 3 • through end of study up to 72 weeks adverse events were collected for study population as a whole
General disorders other intolerable side effects	14.1% 9/64 • Number of events 9 • through end of study up to 72 weeks adverse events were collected for study population as a whole

Additional Information

Samuel B. Ho, MD, Chief GI Section

VA San Diego Healthcare System

Phone: 858-552-8585

Email: samuel.ho2@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place