Trial Outcomes & Findings for Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin (NCT NCT00491179)

Last Updated: 2009-11-13

Results Overview

1. Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection \< 25 IU/mL) 2. Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

1.5 year

Results posted on

2009-11-13

Participant Flow

Recruitment period: June 2006- June 2007 Location: 5 academic centers

Wash out period: 6 months after last interferon intervention

Participant milestones

Participant milestones
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Overall Study STARTED	25	10
Overall Study COMPLETED	18	8
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Overall Study Adverse Event	5	1
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) n=25 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) n=10 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	10 Participants n=4 Participants	35 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	48 years STANDARD_DEVIATION 8 • n=93 Participants	44 years STANDARD_DEVIATION 12 • n=4 Participants	47 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	6 Participants n=4 Participants	23 Participants n=27 Participants
Region of Enrollment Taiwan	25 participants n=93 Participants	10 participants n=4 Participants	35 participants n=27 Participants

PRIMARY outcome

Timeframe: 1.5 year

Population: Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward

Outcome measures

Outcome measures
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) n=25 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) n=10 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs) Drop-out	7 Participants	2 Participants
1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs) Sustained virologic response (SVR)	13 Participants	8 Participants

SECONDARY outcome

Timeframe: 1.5 year

Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)

Outcome measures

Outcome measures
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) n=25 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) n=10 Participants Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Number of Participants With Histologic Response(HR)	11 Participants	6 Participants

Adverse Events

Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) n=25 participants at risk Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) n=10 participants at risk Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Eye disorders Optic neuritis	4.0% 1/25 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Respiratory, thoracic and mediastinal disorders Interstitial pneumonia	4.0% 1/25 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests	0.00% 0/10 • 18 months Constitutional symptoms and abnormal laboratory tests

Other adverse events

Additional Information

Chen-Hua Liu

National Taiwan University Hospital

Phone: 886223123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) n=25 participants at risk Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks	Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) n=10 participants at risk Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Infections and infestations Fever	24.0% 6/25 • Number of events 6 • 18 months Constitutional symptoms and abnormal laboratory tests	30.0% 3/10 • Number of events 3 • 18 months Constitutional symptoms and abnormal laboratory tests
Immune system disorders Rigor	24.0% 6/25 • Number of events 6 • 18 months Constitutional symptoms and abnormal laboratory tests	20.0% 2/10 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests
Nervous system disorders Fatigue	56.0% 14/25 • Number of events 14 • 18 months Constitutional symptoms and abnormal laboratory tests	80.0% 8/10 • Number of events 8 • 18 months Constitutional symptoms and abnormal laboratory tests
Nervous system disorders Headache	28.0% 7/25 • Number of events 7 • 18 months Constitutional symptoms and abnormal laboratory tests	40.0% 4/10 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests
Musculoskeletal and connective tissue disorders Myalgia	16.0% 4/25 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Immune system disorders Arthralgia	4.0% 1/25 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Nervous system disorders Insomnia	28.0% 7/25 • Number of events 7 • 18 months Constitutional symptoms and abnormal laboratory tests	40.0% 4/10 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests
Nervous system disorders Irritability	8.0% 2/25 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Nervous system disorders Depression	12.0% 3/25 • Number of events 3 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Gastrointestinal disorders Anorexia	20.0% 5/25 • Number of events 5 • 18 months Constitutional symptoms and abnormal laboratory tests	50.0% 5/10 • Number of events 5 • 18 months Constitutional symptoms and abnormal laboratory tests
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Gastrointestinal disorders Diarrhea	16.0% 4/25 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
General disorders Body weight loss	12.0% 3/25 • Number of events 3 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Skin and subcutaneous tissue disorders Alopecia	24.0% 6/25 • Number of events 6 • 18 months Constitutional symptoms and abnormal laboratory tests	20.0% 2/10 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests
Immune system disorders Aphthous ulcer	16.0% 4/25 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests	20.0% 2/10 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests	10.0% 1/10 • Number of events 1 • 18 months Constitutional symptoms and abnormal laboratory tests
Ear and labyrinth disorders Nasal stuffiness	8.0% 2/25 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests	0.00% 0/10 • 18 months Constitutional symptoms and abnormal laboratory tests
Skin and subcutaneous tissue disorders Dermatitis	16.0% 4/25 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests	30.0% 3/10 • Number of events 3 • 18 months Constitutional symptoms and abnormal laboratory tests
Blood and lymphatic system disorders Anemia	80.0% 20/25 • Number of events 20 • 18 months Constitutional symptoms and abnormal laboratory tests	60.0% 6/10 • Number of events 6 • 18 months Constitutional symptoms and abnormal laboratory tests
Blood and lymphatic system disorders Neutropenia	16.0% 4/25 • Number of events 4 • 18 months Constitutional symptoms and abnormal laboratory tests	20.0% 2/10 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests
Blood and lymphatic system disorders Thrombocytopenia	12.0% 3/25 • Number of events 3 • 18 months Constitutional symptoms and abnormal laboratory tests	20.0% 2/10 • Number of events 2 • 18 months Constitutional symptoms and abnormal laboratory tests