Trial Outcomes & Findings for Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED) (NCT NCT00686777)
NCT ID: NCT00686777
Last Updated: 2017-04-07
Results Overview
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity. HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
Measured at 24 weeks after the end of treatment (at the end of follow-up)
Results posted on
2017-04-07
Participant Flow
Participants could be discontinued from study by meeting prespecified AE discontinuance criteria defined in the protocol. Prespecified adverse event discontinuance criteria included neutrophil count \<500 /mm3, platelet count \<50,000/mm3, and hemoglobin \<8.5 g/dL
Participant milestones
| Measure |
Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Completed 24 Weeks of Treatment
|
69
|
|
Overall Study
Completed 48 Weeks of Treatment
|
65
|
|
Overall Study
Included in Follow-up (All Treated)
|
75
|
|
Overall Study
Completed 24 Weeks of Follow-up
|
70
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Discontinuance Criteria (specified AEs)
|
4
|
|
Overall Study
No Visit
|
1
|
Baseline Characteristics
Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)
Baseline characteristics by cohort
| Measure |
PEG-IFN + Ribavirin
n=75 Participants
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Age, Customized
< 65 yrs
|
64 participants
n=5 Participants
|
|
Age, Customized
≥ 65 yrs
|
11 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 24 weeks after the end of treatment (at the end of follow-up)Population: All treated Participants
SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity. HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.
Outcome measures
| Measure |
PEG-IFN + Ribavirin
n=75 Participants
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
|
30.7 percentage of participants
|
PRIMARY outcome
Timeframe: From time of first treatment to Week 48Prespecified adverse event discontinuance criteria included neutrophil count \<500 /mm3, platelet count \<50,000/mm3, and hemoglobin \<8.5 g/dL.
Outcome measures
| Measure |
PEG-IFN + Ribavirin
n=75 Participants
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Number of Participants Discontinuing Treatment
Due To Decrease in Neutrophil Count
|
3 participants
|
|
Number of Participants Discontinuing Treatment
Due To Decrease in Neutrophil and Platelet Count
|
1 participants
|
|
Number of Participants Discontinuing Treatment
Due To Apathy
|
1 participants
|
|
Number of Participants Discontinuing Treatment
Due To Pleural Effusion
|
1 participants
|
|
Number of Participants Discontinuing Treatment
Due To Pregnancy of Participant's Partner
|
1 participants
|
|
Number of Participants Discontinuing Treatment
Due To No Visit
|
1 participants
|
|
Number of Participants Discontinuing Treatment
Due To Withdrawal by Subject
|
2 participants
|
|
Number of Participants Discontinuing Treatment
Total Number Discontinued
|
10 participants
|
SECONDARY outcome
Timeframe: Measured at 24 weeks of treatment and at EOT (Treatment week 48)Population: All treated Participants
HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Outcome measures
| Measure |
PEG-IFN + Ribavirin
n=75 Participants
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
At 24 Weeks Treatment
|
61.3 percentage of participants
|
|
Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
At End of Treatment
|
66.7 percentage of participants
|
Adverse Events
PEG-IFN + Ribavirin
Serious events: 7 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN + Ribavirin
n=75 participants at risk
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Congenital, familial and genetic disorders
MENINGOCELE
|
1.3%
1/75 • Number of events 1
|
|
Ear and labyrinth disorders
VERTIGO
|
1.3%
1/75 • Number of events 1
|
|
Eye disorders
CATARACT
|
1.3%
1/75 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
1.3%
1/75 • Number of events 1
|
|
Infections and infestations
LABYRINTHITIS
|
1.3%
1/75 • Number of events 1
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.3%
1/75 • Number of events 1
|
|
Nervous system disorders
CEREBRAL VENTRICLE DILATATION
|
1.3%
1/75 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
PREMATURE BABY
|
1.3%
1/75 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
THREATENED LABOUR
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
1.3%
1/75 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
1.3%
1/75 • Number of events 1
|
Other adverse events
| Measure |
PEG-IFN + Ribavirin
n=75 participants at risk
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.3%
4/75 • Number of events 4
|
|
Cardiac disorders
PALPITATIONS
|
5.3%
4/75 • Number of events 6
|
|
Ear and labyrinth disorders
TINNITUS
|
9.3%
7/75 • Number of events 7
|
|
Ear and labyrinth disorders
VERTIGO
|
5.3%
4/75 • Number of events 5
|
|
Eye disorders
ABNORMAL SENSATION IN EYE
|
10.7%
8/75 • Number of events 8
|
|
Eye disorders
ASTHENOPIA
|
10.7%
8/75 • Number of events 10
|
|
Eye disorders
DRY EYE
|
6.7%
5/75 • Number of events 5
|
|
Eye disorders
RETINOPATHY
|
5.3%
4/75 • Number of events 4
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
24.0%
18/75 • Number of events 20
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.3%
4/75 • Number of events 5
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.0%
12/75 • Number of events 18
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
17.3%
13/75 • Number of events 15
|
|
Gastrointestinal disorders
CHEILITIS
|
6.7%
5/75 • Number of events 5
|
|
Gastrointestinal disorders
CONSTIPATION
|
21.3%
16/75 • Number of events 17
|
|
Gastrointestinal disorders
DIARRHOEA
|
34.7%
26/75 • Number of events 43
|
|
Gastrointestinal disorders
GASTRITIS
|
8.0%
6/75 • Number of events 6
|
|
Gastrointestinal disorders
NAUSEA
|
58.7%
44/75 • Number of events 57
|
|
Gastrointestinal disorders
STOMATITIS
|
38.7%
29/75 • Number of events 36
|
|
Gastrointestinal disorders
VOMITING
|
20.0%
15/75 • Number of events 21
|
|
General disorders
CHEST PAIN
|
5.3%
4/75 • Number of events 4
|
|
General disorders
CHILLS
|
14.7%
11/75 • Number of events 11
|
|
General disorders
FATIGUE
|
6.7%
5/75 • Number of events 5
|
|
General disorders
FEELING COLD
|
9.3%
7/75 • Number of events 7
|
|
General disorders
INJECTION SITE ERYTHEMA
|
40.0%
30/75 • Number of events 30
|
|
General disorders
INJECTION SITE PRURITUS
|
34.7%
26/75 • Number of events 26
|
|
General disorders
INJECTION SITE RASH
|
14.7%
11/75 • Number of events 12
|
|
General disorders
MALAISE
|
88.0%
66/75 • Number of events 84
|
|
General disorders
PAIN
|
5.3%
4/75 • Number of events 4
|
|
General disorders
PYREXIA
|
97.3%
73/75 • Number of events 98
|
|
General disorders
THIRST
|
13.3%
10/75 • Number of events 11
|
|
Infections and infestations
CYSTITIS
|
5.3%
4/75 • Number of events 4
|
|
Infections and infestations
NASOPHARYNGITIS
|
46.7%
35/75 • Number of events 51
|
|
Infections and infestations
PHARYNGITIS
|
5.3%
4/75 • Number of events 4
|
|
Injury, poisoning and procedural complications
CONTUSION
|
5.3%
4/75 • Number of events 4
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
29.3%
22/75 • Number of events 22
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
29.3%
22/75 • Number of events 23
|
|
Investigations
BASOPHIL COUNT INCREASED
|
18.7%
14/75 • Number of events 16
|
|
Investigations
BILIRUBIN CONJUGATED INCREASED
|
6.7%
5/75 • Number of events 5
|
|
Investigations
BLOOD ALBUMIN DECREASED
|
5.3%
4/75 • Number of events 5
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
6.7%
5/75 • Number of events 5
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
10.7%
8/75 • Number of events 9
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
18.7%
14/75 • Number of events 15
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
10.7%
8/75 • Number of events 10
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
22.7%
17/75 • Number of events 18
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
8.0%
6/75 • Number of events 8
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
26.7%
20/75 • Number of events 28
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
21.3%
16/75 • Number of events 16
|
|
Investigations
HAEMATOCRIT DECREASED
|
77.3%
58/75 • Number of events 62
|
|
Investigations
HAEMOGLOBIN DECREASED
|
77.3%
58/75 • Number of events 65
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
94.7%
71/75 • Number of events 83
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
28.0%
21/75 • Number of events 24
|
|
Investigations
MONOCYTE COUNT INCREASED
|
5.3%
4/75 • Number of events 7
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
92.0%
69/75 • Number of events 90
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
10.7%
8/75 • Number of events 14
|
|
Investigations
PLATELET COUNT DECREASED
|
57.3%
43/75 • Number of events 53
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
78.7%
59/75 • Number of events 63
|
|
Investigations
RETICULOCYTE PERCENTAGE DECREASED
|
9.3%
7/75 • Number of events 10
|
|
Investigations
RETICULOCYTE PERCENTAGE INCREASED
|
45.3%
34/75 • Number of events 43
|
|
Investigations
THYROXINE FREE DECREASED
|
8.0%
6/75 • Number of events 6
|
|
Investigations
TRI-IODOTHYRONINE FREE DECREASED
|
10.7%
8/75 • Number of events 9
|
|
Investigations
TRI-IODOTHYRONINE FREE INCREASED
|
6.7%
5/75 • Number of events 5
|
|
Investigations
WEIGHT DECREASED
|
45.3%
34/75 • Number of events 35
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
97.3%
73/75 • Number of events 83
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
72.0%
54/75 • Number of events 66
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
66.7%
50/75 • Number of events 63
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
24.0%
18/75 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
12.0%
9/75 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
65.3%
49/75 • Number of events 64
|
|
Nervous system disorders
DIZZINESS
|
22.7%
17/75 • Number of events 23
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
6.7%
5/75 • Number of events 6
|
|
Nervous system disorders
DYSGEUSIA
|
22.7%
17/75 • Number of events 18
|
|
Nervous system disorders
HEADACHE
|
90.7%
68/75 • Number of events 86
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.7%
5/75 • Number of events 7
|
|
Psychiatric disorders
INSOMNIA
|
57.3%
43/75 • Number of events 56
|
|
Psychiatric disorders
MOOD ALTERED
|
5.3%
4/75 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
21.3%
16/75 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
6.7%
5/75 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.3%
4/75 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL DISCOMFORT
|
5.3%
4/75 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
16.0%
12/75 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
8.0%
6/75 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT INFLAMMATION
|
8.0%
6/75 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
84.0%
63/75 • Number of events 64
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.0%
6/75 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
13.3%
10/75 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
48.0%
36/75 • Number of events 41
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
16.0%
12/75 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
RASH
|
54.7%
41/75 • Number of events 49
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
9.3%
7/75 • Number of events 7
|
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