Trial Outcomes & Findings for Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116) (NCT NCT00687219)
NCT ID: NCT00687219
Last Updated: 2017-04-07
Results Overview
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Measured at 24 weeks after 48 weeks treatment (72 weeks)
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Peginterferon Alfa-2b + Ribavirin
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2b + Ribavirin
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Discontinuance criteria met
|
7
|
|
Overall Study
HCV-RNA positive conversion
|
34
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 Participants
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 24 weeks after 48 weeks treatment (72 weeks)Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Outcome measures
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 Participants
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
Undetectable HCV-RNA
|
41 Participants
|
|
Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
Detectable HCV-RNA
|
40 Participants
|
|
Number of Participants With Undetectable HCV-RNA at Week 72 (Sustained Virologic Response)
Unknown (data not available)
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Peginterferon alfa-2b administered at 1.0 μg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Outcome measures
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 Participants
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Number of Participants With Undetectable HCV-RNA at Week 24
Undetectable HCV-RNA
|
61 Participants
|
|
Number of Participants With Undetectable HCV-RNA at Week 24
Detectable HCV-RNA
|
35 Participants
|
|
Number of Participants With Undetectable HCV-RNA at Week 24
Unknown (data not available)
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 48 weeksSerum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
Outcome measures
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 Participants
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Number of Participants With Undetectable HCV-RNA at End of Treatment
Undetectable HCV-RNA
|
59 Participants
|
|
Number of Participants With Undetectable HCV-RNA at End of Treatment
Detectable HCV-RNA
|
43 Participants
|
|
Number of Participants With Undetectable HCV-RNA at End of Treatment
Unknown (data not available)
|
0 Participants
|
Adverse Events
Peginterferon Alfa-2b + Ribavirin
Serious events: 14 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 participants at risk
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.98%
1/102 • Number of events 1
|
|
Eye disorders
CATARACT
|
2.0%
2/102 • Number of events 2
|
|
Eye disorders
DIPLOPIA
|
0.98%
1/102 • Number of events 1
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.98%
1/102 • Number of events 1
|
|
General disorders
MALAISE
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.98%
1/102 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.98%
1/102 • Number of events 1
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.98%
1/102 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
3.9%
4/102 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.98%
1/102 • Number of events 1
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.98%
1/102 • Number of events 1
|
Other adverse events
| Measure |
Peginterferon Alfa-2b + Ribavirin
n=102 participants at risk
Peginterferon alfa-2b administered at 1.0 µg/kg/week SC for 48 weeks plus ribavirin administered based on body weight and hemoglobin value at screening: 600-1000 mg/day
for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL for 48 weeks
|
|---|---|
|
Cardiac disorders
PALPITATIONS
|
5.9%
6/102 • Number of events 7
|
|
Eye disorders
EYE PRURITUS
|
7.8%
8/102 • Number of events 8
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
16.7%
17/102 • Number of events 18
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
11.8%
12/102 • Number of events 14
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.9%
7/102 • Number of events 8
|
|
Gastrointestinal disorders
CONSTIPATION
|
17.6%
18/102 • Number of events 22
|
|
Gastrointestinal disorders
DIARRHOEA
|
19.6%
20/102 • Number of events 28
|
|
Gastrointestinal disorders
NAUSEA
|
36.3%
37/102 • Number of events 48
|
|
Gastrointestinal disorders
STOMATITIS
|
24.5%
25/102 • Number of events 30
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
5.9%
6/102 • Number of events 6
|
|
Gastrointestinal disorders
VOMITING
|
12.7%
13/102 • Number of events 17
|
|
General disorders
CHILLS
|
5.9%
6/102 • Number of events 6
|
|
General disorders
INJECTION SITE ERYTHEMA
|
42.2%
43/102 • Number of events 47
|
|
General disorders
INJECTION SITE PRURITUS
|
26.5%
27/102 • Number of events 30
|
|
General disorders
INJECTION SITE RASH
|
9.8%
10/102 • Number of events 11
|
|
General disorders
MALAISE
|
88.2%
90/102 • Number of events 103
|
|
General disorders
OEDEMA PERIPHERAL
|
7.8%
8/102 • Number of events 9
|
|
General disorders
PYREXIA
|
94.1%
96/102 • Number of events 122
|
|
General disorders
THIRST
|
10.8%
11/102 • Number of events 11
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
5.9%
6/102 • Number of events 6
|
|
Infections and infestations
NASOPHARYNGITIS
|
35.3%
36/102 • Number of events 54
|
|
Infections and infestations
PHARYNGITIS
|
5.9%
6/102 • Number of events 7
|
|
Injury, poisoning and procedural complications
CONTUSION
|
6.9%
7/102 • Number of events 7
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
25.5%
26/102 • Number of events 28
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
30.4%
31/102 • Number of events 32
|
|
Investigations
BASOPHIL COUNT INCREASED
|
16.7%
17/102 • Number of events 20
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
7.8%
8/102 • Number of events 10
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
6.9%
7/102 • Number of events 7
|
|
Investigations
BLOOD AMYLASE INCREASED
|
32.4%
33/102 • Number of events 44
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
17.6%
18/102 • Number of events 25
|
|
Investigations
BLOOD BILIRUBIN UNCONJUGATED INCREASED
|
30.4%
31/102 • Number of events 36
|
|
Investigations
BLOOD CHLORIDE INCREASED
|
8.8%
9/102 • Number of events 9
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
22.5%
23/102 • Number of events 25
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
14.7%
15/102 • Number of events 17
|
|
Investigations
BLOOD PRESSURE INCREASED
|
8.8%
9/102 • Number of events 9
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
8.8%
9/102 • Number of events 9
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
17.6%
18/102 • Number of events 22
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
31.4%
32/102 • Number of events 39
|
|
Investigations
BLOOD URIC ACID INCREASED
|
14.7%
15/102 • Number of events 16
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
10.8%
11/102 • Number of events 11
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
18.6%
19/102 • Number of events 22
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
26.5%
27/102 • Number of events 28
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN DECREASED
|
7.8%
8/102 • Number of events 9
|
|
Investigations
HAEMATOCRIT DECREASED
|
80.4%
82/102 • Number of events 87
|
|
Investigations
HAEMOGLOBIN DECREASED
|
89.2%
91/102 • Number of events 94
|
|
Investigations
HYALURONIC ACID INCREASED
|
51.0%
52/102 • Number of events 59
|
|
Investigations
LIPASE INCREASED
|
32.4%
33/102 • Number of events 45
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
87.3%
89/102 • Number of events 107
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
31.4%
32/102 • Number of events 45
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
85.3%
87/102 • Number of events 113
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
16.7%
17/102 • Number of events 21
|
|
Investigations
PLATELET COUNT DECREASED
|
63.7%
65/102 • Number of events 76
|
|
Investigations
PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST II INCREASED
|
8.8%
9/102 • Number of events 9
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
84.3%
86/102 • Number of events 88
|
|
Investigations
RETICULOCYTE COUNT DECREASED
|
5.9%
6/102 • Number of events 6
|
|
Investigations
RETICULOCYTE COUNT INCREASED
|
7.8%
8/102 • Number of events 8
|
|
Investigations
RETICULOCYTE PERCENTAGE DECREASED
|
14.7%
15/102 • Number of events 17
|
|
Investigations
RETICULOCYTE PERCENTAGE INCREASED
|
54.9%
56/102 • Number of events 62
|
|
Investigations
THYROXINE FREE DECREASED
|
7.8%
8/102 • Number of events 8
|
|
Investigations
TRI-IODOTHYRONINE FREE DECREASED
|
8.8%
9/102 • Number of events 9
|
|
Investigations
WEIGHT DECREASED
|
35.3%
36/102 • Number of events 36
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
92.2%
94/102 • Number of events 108
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
59.8%
61/102 • Number of events 77
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
54.9%
56/102 • Number of events 70
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
32.4%
33/102 • Number of events 36
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
9.8%
10/102 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
6.9%
7/102 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
54.9%
56/102 • Number of events 70
|
|
Nervous system disorders
DIZZINESS
|
20.6%
21/102 • Number of events 24
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
8.8%
9/102 • Number of events 9
|
|
Nervous system disorders
DYSGEUSIA
|
12.7%
13/102 • Number of events 14
|
|
Nervous system disorders
HEADACHE
|
81.4%
83/102 • Number of events 111
|
|
Psychiatric disorders
INSOMNIA
|
44.1%
45/102 • Number of events 52
|
|
Psychiatric disorders
MOOD ALTERED
|
7.8%
8/102 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.6%
21/102 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.8%
10/102 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
12.7%
13/102 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
13.7%
14/102 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
46.1%
47/102 • Number of events 47
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
5.9%
6/102 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.8%
9/102 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
9.8%
10/102 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
11.8%
12/102 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
33.3%
34/102 • Number of events 42
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
8.8%
9/102 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
RASH
|
39.2%
40/102 • Number of events 47
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place