Trial Outcomes & Findings for Study of Long-term Peg Intron vs. Colchicine in Non-responders. (NCT NCT00179413)

Last Updated: 2017-07-11

Results Overview

number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of \> 2 points and development of hepatoma

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

549 participants

Primary outcome timeframe

4 years

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	PEG-Intron PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine 0.6mg twice a day Colchicine: 0.6mg twice a day
Overall Study STARTED	282	267
Overall Study COMPLETED	157	152
Overall Study NOT COMPLETED	125	115

Reasons for withdrawal

Reasons for withdrawal
Measure	PEG-Intron PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine 0.6mg twice a day Colchicine: 0.6mg twice a day
Overall Study Adverse Event	38	20
Overall Study Withdrawal by Subject	87	95

Baseline Characteristics

Study of Long-term Peg Intron vs. Colchicine in Non-responders.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEG-Intron n=282 Participants PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=267 Participants 0.6mg twice a day Colchicine: 0.6mg twice a day	Total n=549 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 8.4 • n=5 Participants	50.4 years STANDARD_DEVIATION 7.1 • n=7 Participants	50.2 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants	77 Participants n=7 Participants	167 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	190 Participants n=7 Participants	382 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	6 Participants n=5 Participants	3 Participants n=7 Participants	9 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	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Race (NIH/OMB) White	240 Participants n=5 Participants	227 Participants n=7 Participants	467 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	282 participants n=5 Participants	267 participants n=7 Participants	549 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 years

Outcome measures

Outcome measures
Measure	PEG-Intron n=282 Participants PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=267 Participants 0.6mg twice a day Colchicine: 0.6mg twice a day
Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on:	53 Participants	59 Participants

SECONDARY outcome

Timeframe: 4 years

Defined as the number of patients who discontinued therapy due to an adverse event side

Outcome measures

Outcome measures
Measure	PEG-Intron n=282 Participants PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=267 Participants 0.6mg twice a day Colchicine: 0.6mg twice a day
Evaluation of Safety and Tolerability of Long Term Maintenance PEG-Intron in Patients With Cirrhosis	38 Participants	20 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The number of patients at risk include only those patients who at the baseline endoscopy had no evidence of portal hypertension or varices

Number of patients who develop endoscopic evidence of varices over 4 year period

Outcome measures

Outcome measures
Measure	PEG-Intron n=92 Participants PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=92 Participants 0.6mg twice a day Colchicine: 0.6mg twice a day
Development of Portal Hypertension	12 Participants	24 Participants

Adverse Events

PEG-Intron

Serious events: 90 serious events

Other events: 257 other events

Deaths: 0 deaths

Colchicine

Serious events: 79 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PEG-Intron n=282 participants at risk PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=267 participants at risk 0.6mg twice a day Colchicine: 0.6mg twice a day
Nervous system disorders Depression	1.1% 3/282 • Number of events 3 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	0.37% 1/267 • Number of events 1 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event
Blood and lymphatic system disorders Thrombocytopenia	1.4% 4/282 • Number of events 4 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	1.5% 4/267 • Number of events 4 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event
General disorders Fatigue, asthenia	11.0% 31/282 • Number of events 31 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	5.6% 15/267 • Number of events 15 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event
Hepatobiliary disorders Disease progression	18.8% 53/282 • Number of events 53 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	22.1% 59/267 • Number of events 59 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event

Other adverse events

Other adverse events
Measure	PEG-Intron n=282 participants at risk PEG-Intron 0.5mcg/kg once a week SC PEG -Intron	Colchicine n=267 participants at risk 0.6mg twice a day Colchicine: 0.6mg twice a day
General disorders flu like symptoms	85.8% 242/282 • Number of events 242 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	3.0% 8/267 • Number of events 8 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event
Gastrointestinal disorders diarrhea	5.3% 15/282 • Number of events 15 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event	13.5% 36/267 • Number of events 36 • Four years on treatment Although not included as an Adverse event in the clinical trial design but rather as a primary endpoint, liver disease progression has now been added as an adverse event

Additional Information

Dr. Nezam Afdhal

BIDMC

Phone: 617632118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place