Trial Outcomes & Findings for Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548) (NCT NCT00302081)
NCT ID: NCT00302081
Last Updated: 2017-04-05
Results Overview
A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid \[HCV-RNA\] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
696 participants
Primary outcome timeframe
24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.
Results posted on
2017-04-05
Participant Flow
696 subjects were randomized. 14 subjects never received any study drug and, therefore, were excluded from the Intent to Treat (ITT) population. ITT population consisted of 682 subjects.
Participant milestones
| Measure |
PEG2b 1.5/R (24 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
|
PEG2b 1.0/R (24 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
|
PEG2b 1.5/R (16 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
237
|
229
|
230
|
|
Overall Study
COMPLETED
|
181
|
186
|
178
|
|
Overall Study
NOT COMPLETED
|
56
|
43
|
52
|
Reasons for withdrawal
| Measure |
PEG2b 1.5/R (24 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
|
PEG2b 1.0/R (24 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
|
PEG2b 1.5/R (16 Weeks)
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
21
|
18
|
28
|
|
Overall Study
Withdrawal by Subject
|
8
|
12
|
8
|
|
Overall Study
Protocol Violation
|
5
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
5
|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Other
|
13
|
6
|
5
|
Baseline Characteristics
Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)
Baseline characteristics by cohort
| Measure |
PEG2b 1.5/R (24 Weeks)
n=230 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
|
PEG2b 1.0/R (24 Weeks)
n=224 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
|
PEG2b 1.5/R (16 Weeks)
n=228 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
|
Total
n=682 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
433 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24-week treatment duration for Arms [Peg2b 1.5/R(24 weeks)] and [PEG2b 1.0/R(24 weeks]); 16-week treatment duration for Arm [PEG2b 1.5/R(16 weeks]. Follow-up of 24 weeks for each arm.Population: Intent-to-Treat (ITT) population
A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid \[HCV-RNA\] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.
Outcome measures
| Measure |
PEG2b 1.5/R (24 Weeks)
n=230 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
|
PEG2b 1.0/R (24 Weeks)
n=224 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
|
PEG2b 1.5/R (16 Weeks)
n=228 Participants
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
|
|---|---|---|---|
|
The Number of Participants Who Achieve a Sustained Virologic Response (SVR)
|
153 participants
|
144 participants
|
129 participants
|
SECONDARY outcome
Timeframe: End of treatment: 24 weeks for arms [PEG2b 1.5/R (24 weeks)] and [PEG2b 1.0/R (24 weeks)]; 16 weeks for arm [PEG2b 1.5/R (16 weeks)]. Follow-up of 24 weeks for each arm.Virologic response is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) in the serum. A blood test is used to measure the level of ALT and AST. ALT response was defined as ALT\<40 IU/L (international units per liter). This was not a prespecified key secondary outcome.
Outcome measures
Outcome data not reported
Adverse Events
PEG2b 1.5/R*(24 Weeks)
Serious events: 14 serious events
Other events: 196 other events
Deaths: 0 deaths
PEG2b 1.0/R*(24 Weeks)
Serious events: 11 serious events
Other events: 187 other events
Deaths: 0 deaths
PEG2b 1.5/R*(16 Weeks)
Serious events: 7 serious events
Other events: 201 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG2b 1.5/R*(24 Weeks)
n=230 participants at risk
|
PEG2b 1.0/R*(24 Weeks)
n=224 participants at risk
|
PEG2b 1.5/R*(16 Weeks)
n=228 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.87%
2/230 • Number of events 2
|
0.00%
0/224
|
0.00%
0/228
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Cardiac disorders
PALPITATIONS
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Eye disorders
AMAUROSIS FUGAX
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Eye disorders
RETINAL DETACHMENT
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
General disorders
HERNIA
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
General disorders
PYREXIA
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Hepatobiliary disorders
JAUNDICE
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Infections and infestations
GASTROENTERITIS
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.87%
2/230 • Number of events 2
|
0.00%
0/224
|
0.00%
0/228
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Nervous system disorders
COMA
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Nervous system disorders
SOMNOLENCE
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
AGGRESSION
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
AGITATION
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Psychiatric disorders
ANGER
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
ANXIETY
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Psychiatric disorders
INSOMNIA
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
NERVOUSNESS
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
PERSECUTORY DELUSION
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
|
Renal and urinary disorders
NEPHROPATHY
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.43%
1/230 • Number of events 1
|
0.00%
0/224
|
0.00%
0/228
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/230
|
0.00%
0/224
|
0.44%
1/228 • Number of events 1
|
|
Social circumstances
PREGNANCY OF PARTNER
|
0.00%
0/230
|
0.45%
1/224 • Number of events 1
|
0.00%
0/228
|
Other adverse events
| Measure |
PEG2b 1.5/R*(24 Weeks)
n=230 participants at risk
|
PEG2b 1.0/R*(24 Weeks)
n=224 participants at risk
|
PEG2b 1.5/R*(16 Weeks)
n=228 participants at risk
|
|---|---|---|---|
|
Psychiatric disorders
INSOMNIA
|
7.4%
17/230 • Number of events 19
|
4.9%
11/224 • Number of events 11
|
4.4%
10/228 • Number of events 11
|
|
Psychiatric disorders
SLEEP DISORDER
|
8.3%
19/230 • Number of events 22
|
2.7%
6/224 • Number of events 6
|
3.1%
7/228 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
8.3%
19/230 • Number of events 21
|
9.8%
22/224 • Number of events 28
|
9.6%
22/228 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.7%
13/230 • Number of events 14
|
6.2%
14/224 • Number of events 15
|
3.9%
9/228 • Number of events 9
|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.6%
22/230 • Number of events 27
|
4.9%
11/224 • Number of events 12
|
11.0%
25/228 • Number of events 26
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.1%
14/230 • Number of events 16
|
7.6%
17/224 • Number of events 18
|
9.6%
22/228 • Number of events 22
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
4.8%
11/230 • Number of events 11
|
4.9%
11/224 • Number of events 14
|
5.3%
12/228 • Number of events 12
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.8%
11/230 • Number of events 11
|
8.0%
18/224 • Number of events 21
|
3.9%
9/228 • Number of events 13
|
|
Gastrointestinal disorders
DIARRHOEA
|
9.6%
22/230 • Number of events 28
|
12.1%
27/224 • Number of events 28
|
7.0%
16/228 • Number of events 18
|
|
Gastrointestinal disorders
DRY MOUTH
|
5.2%
12/230 • Number of events 12
|
2.2%
5/224 • Number of events 5
|
1.8%
4/228 • Number of events 4
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.8%
11/230 • Number of events 13
|
8.9%
20/224 • Number of events 25
|
6.1%
14/228 • Number of events 18
|
|
Gastrointestinal disorders
NAUSEA
|
11.7%
27/230 • Number of events 32
|
11.6%
26/224 • Number of events 29
|
13.6%
31/228 • Number of events 34
|
|
Gastrointestinal disorders
VOMITING
|
2.6%
6/230 • Number of events 6
|
5.4%
12/224 • Number of events 13
|
3.1%
7/228 • Number of events 7
|
|
General disorders
ASTHENIA
|
19.1%
44/230 • Number of events 74
|
27.7%
62/224 • Number of events 75
|
19.7%
45/228 • Number of events 63
|
|
General disorders
CHILLS
|
5.7%
13/230 • Number of events 15
|
5.8%
13/224 • Number of events 14
|
7.0%
16/228 • Number of events 17
|
|
General disorders
FATIGUE
|
22.6%
52/230 • Number of events 64
|
22.3%
50/224 • Number of events 57
|
15.8%
36/228 • Number of events 43
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
12.6%
29/230 • Number of events 35
|
9.4%
21/224 • Number of events 24
|
10.1%
23/228 • Number of events 31
|
|
General disorders
INJECTION SITE ERYTHEMA
|
11.3%
26/230 • Number of events 27
|
13.8%
31/224 • Number of events 40
|
7.5%
17/228 • Number of events 18
|
|
General disorders
IRRITABILITY
|
3.5%
8/230 • Number of events 11
|
6.2%
14/224 • Number of events 15
|
4.4%
10/228 • Number of events 10
|
|
General disorders
PAIN
|
7.4%
17/230 • Number of events 56
|
5.8%
13/224 • Number of events 55
|
5.7%
13/228 • Number of events 53
|
|
General disorders
PYREXIA
|
37.8%
87/230 • Number of events 328
|
37.1%
83/224 • Number of events 300
|
44.3%
101/228 • Number of events 296
|
|
Investigations
HAEMOGLOBIN DECREASED
|
5.2%
12/230 • Number of events 14
|
3.1%
7/224 • Number of events 7
|
4.8%
11/228 • Number of events 14
|
|
Investigations
WEIGHT DECREASED
|
12.6%
29/230 • Number of events 29
|
10.7%
24/224 • Number of events 24
|
13.6%
31/228 • Number of events 31
|
|
Metabolism and nutrition disorders
ANOREXIA
|
12.2%
28/230 • Number of events 32
|
4.9%
11/224 • Number of events 12
|
9.6%
22/228 • Number of events 23
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
3.5%
8/230 • Number of events 8
|
6.2%
14/224 • Number of events 14
|
5.3%
12/228 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.9%
25/230 • Number of events 27
|
7.6%
17/224 • Number of events 22
|
10.5%
24/228 • Number of events 27
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.8%
11/230 • Number of events 14
|
4.9%
11/224 • Number of events 12
|
5.3%
12/228 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
15.2%
35/230 • Number of events 64
|
12.1%
27/224 • Number of events 31
|
14.9%
34/228 • Number of events 35
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.5%
8/230 • Number of events 12
|
7.1%
16/224 • Number of events 22
|
6.6%
15/228 • Number of events 16
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
3.9%
9/230 • Number of events 9
|
5.8%
13/224 • Number of events 13
|
0.88%
2/228 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
5.7%
13/230 • Number of events 16
|
2.2%
5/224 • Number of events 7
|
3.9%
9/228 • Number of events 10
|
|
Nervous system disorders
HEADACHE
|
22.6%
52/230 • Number of events 74
|
25.4%
57/224 • Number of events 98
|
25.4%
58/228 • Number of events 78
|
|
Psychiatric disorders
DEPRESSED MOOD
|
10.9%
25/230 • Number of events 26
|
7.1%
16/224 • Number of events 17
|
8.3%
19/228 • Number of events 19
|
|
Psychiatric disorders
DEPRESSION
|
8.3%
19/230 • Number of events 20
|
4.9%
11/224 • Number of events 13
|
3.1%
7/228 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
20.9%
48/230 • Number of events 49
|
16.1%
36/224 • Number of events 37
|
13.6%
31/228 • Number of events 31
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.7%
13/230 • Number of events 14
|
11.2%
25/224 • Number of events 26
|
6.6%
15/228 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.6%
29/230 • Number of events 35
|
19.6%
44/224 • Number of events 49
|
10.1%
23/228 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.1%
14/230 • Number of events 15
|
6.7%
15/224 • Number of events 18
|
5.3%
12/228 • Number of events 14
|
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
Restriction type: LTE60