Trial Outcomes & Findings for Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C (NCT NCT00491244)
NCT ID: NCT00491244
Last Updated: 2014-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
377 participants
Primary outcome timeframe
1.5 year
Results posted on
2014-02-10
Participant Flow
Recruitment from 1 June, 2007 to 9 May, 2012 Location: 8 academic centers in Taiwan
Participant milestones
| Measure |
Peginterferon and Ribavirin
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
188
|
|
Overall Study
COMPLETED
|
162
|
168
|
|
Overall Study
NOT COMPLETED
|
27
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Peginterferon and Ribavirin
n=189 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
n=188 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Total
n=377 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
|
189 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
377 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 years
STANDARD_DEVIATION 10 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11 • n=7 Participants
|
51 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
189 participants
n=5 Participants
|
188 participants
n=7 Participants
|
377 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 yearPopulation: All participants were analyzed if they received at least one dose of the study medication
Outcome measures
| Measure |
Peginterferon and Ribavirin
n=189 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
n=188 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
|---|---|---|
|
Sustained Virologic Response (SVR)Rate
|
130 participants
|
72 participants
|
SECONDARY outcome
Timeframe: 1.5 yearPopulation: All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit
Outcome measures
| Measure |
Peginterferon and Ribavirin
n=189 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
n=188 Participants
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
|---|---|---|
|
Adverse Event (AE)-Related Withdrawal Rate
Advese event related withdrawal rate
|
12 participants
|
7 participants
|
|
Adverse Event (AE)-Related Withdrawal Rate
Non withdrawal
|
177 participants
|
171 participants
|
Adverse Events
Peginterferon and Ribavirin
Serious events: 8 serious events
Other events: 170 other events
Deaths: 0 deaths
Peginterferon
Serious events: 7 serious events
Other events: 154 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon and Ribavirin
n=189 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 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
n=188 participants at risk
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
|---|---|---|
|
Infections and infestations
Cholangitis
|
0.00%
0/189 • 18 months
|
0.53%
1/188 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Intractable diarrhea
|
0.53%
1/189 • Number of events 1 • 18 months
|
0.00%
0/188 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.53%
1/189 • Number of events 1 • 18 months
|
0.00%
0/188 • 18 months
|
|
Psychiatric disorders
Major depression
|
0.00%
0/189 • 18 months
|
0.53%
1/188 • Number of events 1 • 18 months
|
|
Gastrointestinal disorders
Peptic ulcer bleeding
|
0.00%
0/189 • 18 months
|
0.53%
1/188 • Number of events 1 • 18 months
|
|
Infections and infestations
Peritonitis
|
0.53%
1/189 • Number of events 1 • 18 months
|
0.00%
0/188 • 18 months
|
|
Infections and infestations
Pneumonia
|
1.1%
2/189 • Number of events 2 • 18 months
|
1.6%
3/188 • Number of events 3 • 18 months
|
|
Cardiac disorders
Postural dizziness
|
1.1%
2/189 • Number of events 2 • 18 months
|
0.00%
0/188 • 18 months
|
|
Infections and infestations
Salmonella gastroenteritis
|
0.00%
0/189 • 18 months
|
0.53%
1/188 • Number of events 1 • 18 months
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson sybdrome
|
0.53%
1/189 • Number of events 1 • 18 months
|
0.00%
0/188 • 18 months
|
Other adverse events
| Measure |
Peginterferon and Ribavirin
n=189 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 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
Peginterferon
n=188 participants at risk
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
|
|---|---|---|
|
Immune system disorders
Flu-like syndrome
|
24.9%
47/189 • Number of events 47 • 18 months
|
26.6%
50/188 • Number of events 50 • 18 months
|
|
Nervous system disorders
Fatigue
|
56.1%
106/189 • Number of events 106 • 18 months
|
51.6%
97/188 • Number of events 97 • 18 months
|
|
Nervous system disorders
Headache
|
27.0%
51/189 • Number of events 51 • 18 months
|
25.5%
48/188 • Number of events 48 • 18 months
|
|
Nervous system disorders
Insomnia
|
32.8%
62/189 • Number of events 62 • 18 months
|
35.1%
66/188 • Number of events 66 • 18 months
|
|
Psychiatric disorders
Irritability
|
11.1%
21/189 • Number of events 21 • 18 months
|
10.1%
19/188 • Number of events 19 • 18 months
|
|
Psychiatric disorders
Depression
|
13.2%
25/189 • Number of events 25 • 18 months
|
12.2%
23/188 • Number of events 23 • 18 months
|
|
Gastrointestinal disorders
Anorexia
|
23.3%
44/189 • Number of events 44 • 18 months
|
20.2%
38/188 • Number of events 38 • 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.6%
22/189 • Number of events 22 • 18 months
|
10.6%
20/188 • Number of events 20 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
8.5%
16/189 • Number of events 16 • 18 months
|
8.0%
15/188 • Number of events 15 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
26/189 • Number of events 26 • 18 months
|
5.3%
10/188 • Number of events 10 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
22.8%
43/189 • Number of events 43 • 18 months
|
20.2%
38/188 • Number of events 38 • 18 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
14.3%
27/189 • Number of events 27 • 18 months
|
14.4%
27/188 • Number of events 27 • 18 months
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
24.9%
47/189 • Number of events 47 • 18 months
|
22.9%
43/188 • Number of events 43 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
70.9%
134/189 • Number of events 134 • 18 months
|
6.9%
13/188 • Number of events 13 • 18 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.9%
30/189 • Number of events 30 • 18 months
|
13.8%
26/188 • Number of events 26 • 18 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.1%
19/189 • Number of events 19 • 18 months
|
11.2%
21/188 • Number of events 21 • 18 months
|
Additional Information
Dr. Chen-Hua Liu
National Taiwan University Hospital
Phone: +886-2-23123456
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place