Trial Outcomes & Findings for Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED) (NCT NCT00255034)
NCT ID: NCT00255034
Last Updated: 2017-04-06
Results Overview
No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
146 participants
Primary outcome timeframe
24 weeks after completion of either up to 24 or 48 weeks of therapy
Results posted on
2017-04-06
Participant Flow
The target recruitment was not attained within the anticipated study time-frame and so study recruitment was ceased on 24 November 2006; however those patients already enrolled in the study continued in the study until completion.
Enrolled 146 subjects; 143 subjects were treated; 3 subjects were withdrawn at Baseline and never received study medication: 1 subject in the 24 weeks group due to consent issues; and 2 subjects in the 48 weeks group (1 subject was ineligible and 1 subject was randomized in error).
Participant milestones
| Measure |
24 Weeks of Therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
|
48 Weeks of Therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
64
|
|
Overall Study
COMPLETED
|
64
|
26
|
|
Overall Study
NOT COMPLETED
|
15
|
38
|
Reasons for withdrawal
| Measure |
24 Weeks of Therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
|
48 Weeks of Therapy
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
38
|
Baseline Characteristics
Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)
Baseline characteristics by cohort
| Measure |
24 Weeks of Therapy
n=79 Participants
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
|
48 Weeks of Therapy
n=64 Participants
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
40.7 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
27 participants
n=5 Participants
|
12 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after completion of either up to 24 or 48 weeks of therapyPopulation: Data were missing for 1 subject in the "48 weeks of therapy" treatment arm.
No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.
Outcome measures
| Measure |
24 Weeks of Therapy
n=79 Participants
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
|
48 Weeks of Therapy
n=63 Participants
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
|
|---|---|---|
|
Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
|
55 Participants
|
36 Participants
|
Adverse Events
24 Weeks of Therapy
Serious events: 8 serious events
Other events: 79 other events
Deaths: 0 deaths
48 Weeks of Therapy
Serious events: 9 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
24 Weeks of Therapy
n=79 participants at risk
|
48 Weeks of Therapy
n=64 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Endocrine disorders
THYROIDITIS
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/79
|
1.6%
1/64 • Number of events 2
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
General disorders
ABASIA
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Hepatobiliary disorders
BUDD-CHIARI SYNDROME
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
CELLULITIS
|
2.5%
2/79 • Number of events 2
|
0.00%
0/64
|
|
Infections and infestations
MENINGITIS VIRAL
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
SIALOADENITIS
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
WOUND INFECTION
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
NECK INJURY
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
DIZZINESS
|
1.3%
1/79 • Number of events 2
|
0.00%
0/64
|
|
Nervous system disorders
SYNCOPE
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Nervous system disorders
TARDIVE DYSKINESIA
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
ANXIETY
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
DELUSIONAL DISORDER, PERSECUTORY TYPE
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
2.5%
2/79 • Number of events 2
|
0.00%
0/64
|
|
Psychiatric disorders
HYPOMANIA
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.3%
1/79 • Number of events 1
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/79
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
24 Weeks of Therapy
n=79 participants at risk
|
48 Weeks of Therapy
n=64 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.8%
3/79 • Number of events 3
|
7.8%
5/64 • Number of events 6
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.5%
2/79 • Number of events 2
|
10.9%
7/64 • Number of events 9
|
|
Cardiac disorders
PALPITATIONS
|
2.5%
2/79 • Number of events 2
|
6.2%
4/64 • Number of events 4
|
|
Eye disorders
DRY EYE
|
2.5%
2/79 • Number of events 2
|
6.2%
4/64 • Number of events 4
|
|
Eye disorders
VISION BLURRED
|
3.8%
3/79 • Number of events 3
|
10.9%
7/64 • Number of events 7
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
5.1%
4/79 • Number of events 4
|
0.00%
0/64
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.1%
4/79 • Number of events 4
|
4.7%
3/64 • Number of events 3
|
|
Gastrointestinal disorders
CHEILITIS
|
6.3%
5/79 • Number of events 6
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.4%
9/79 • Number of events 10
|
7.8%
5/64 • Number of events 5
|
|
Gastrointestinal disorders
DIARRHOEA
|
22.8%
18/79 • Number of events 18
|
12.5%
8/64 • Number of events 11
|
|
Gastrointestinal disorders
DRY MOUTH
|
10.1%
8/79 • Number of events 8
|
7.8%
5/64 • Number of events 5
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
7.6%
6/79 • Number of events 7
|
4.7%
3/64 • Number of events 3
|
|
Gastrointestinal disorders
NAUSEA
|
35.4%
28/79 • Number of events 34
|
39.1%
25/64 • Number of events 27
|
|
Gastrointestinal disorders
TOOTHACHE
|
3.8%
3/79 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
|
Gastrointestinal disorders
VOMITING
|
11.4%
9/79 • Number of events 13
|
9.4%
6/64 • Number of events 8
|
|
General disorders
CHEST PAIN
|
0.00%
0/79
|
6.2%
4/64 • Number of events 4
|
|
General disorders
CHILLS
|
16.5%
13/79 • Number of events 14
|
15.6%
10/64 • Number of events 10
|
|
General disorders
FATIGUE
|
48.1%
38/79 • Number of events 40
|
46.9%
30/64 • Number of events 34
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
50.6%
40/79 • Number of events 40
|
64.1%
41/64 • Number of events 47
|
|
General disorders
INJECTION SITE ERYTHEMA
|
19.0%
15/79 • Number of events 15
|
21.9%
14/64 • Number of events 14
|
|
General disorders
IRRITABILITY
|
25.3%
20/79 • Number of events 24
|
31.2%
20/64 • Number of events 20
|
|
General disorders
PYREXIA
|
8.9%
7/79 • Number of events 7
|
6.2%
4/64 • Number of events 4
|
|
General disorders
THIRST
|
6.3%
5/79 • Number of events 5
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.5%
2/79 • Number of events 2
|
6.2%
4/64 • Number of events 4
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.9%
7/79 • Number of events 8
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
ORAL CANDIDIASIS
|
5.1%
4/79 • Number of events 4
|
0.00%
0/64
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.6%
6/79 • Number of events 6
|
4.7%
3/64 • Number of events 3
|
|
Investigations
WEIGHT DECREASED
|
7.6%
6/79 • Number of events 6
|
12.5%
8/64 • Number of events 9
|
|
Metabolism and nutrition disorders
ANOREXIA
|
3.8%
3/79 • Number of events 3
|
6.2%
4/64 • Number of events 4
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
27.8%
22/79 • Number of events 26
|
21.9%
14/64 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.5%
13/79 • Number of events 14
|
14.1%
9/64 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
15.2%
12/79 • Number of events 13
|
18.8%
12/64 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
30.4%
24/79 • Number of events 31
|
18.8%
12/64 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.5%
2/79 • Number of events 2
|
9.4%
6/64 • Number of events 7
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
8.9%
7/79 • Number of events 7
|
12.5%
8/64 • Number of events 9
|
|
Nervous system disorders
DIZZINESS
|
10.1%
8/79 • Number of events 9
|
14.1%
9/64 • Number of events 11
|
|
Nervous system disorders
DYSGEUSIA
|
6.3%
5/79 • Number of events 5
|
6.2%
4/64 • Number of events 4
|
|
Nervous system disorders
HEADACHE
|
50.6%
40/79 • Number of events 51
|
53.1%
34/64 • Number of events 41
|
|
Nervous system disorders
LETHARGY
|
22.8%
18/79 • Number of events 21
|
26.6%
17/64 • Number of events 20
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
6.3%
5/79 • Number of events 5
|
6.2%
4/64 • Number of events 4
|
|
Psychiatric disorders
ANXIETY
|
7.6%
6/79 • Number of events 6
|
15.6%
10/64 • Number of events 12
|
|
Psychiatric disorders
DEPRESSED MOOD
|
6.3%
5/79 • Number of events 5
|
7.8%
5/64 • Number of events 6
|
|
Psychiatric disorders
DEPRESSION
|
25.3%
20/79 • Number of events 21
|
26.6%
17/64 • Number of events 20
|
|
Psychiatric disorders
INSOMNIA
|
38.0%
30/79 • Number of events 33
|
29.7%
19/64 • Number of events 21
|
|
Psychiatric disorders
MOOD SWINGS
|
8.9%
7/79 • Number of events 7
|
15.6%
10/64 • Number of events 10
|
|
Psychiatric disorders
SLEEP DISORDER
|
5.1%
4/79 • Number of events 4
|
15.6%
10/64 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.7%
10/79 • Number of events 10
|
9.4%
6/64 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
19.0%
15/79 • Number of events 16
|
12.5%
8/64 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.1%
4/79 • Number of events 4
|
4.7%
3/64 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.8%
3/79 • Number of events 3
|
7.8%
5/64 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.1%
4/79 • Number of events 5
|
1.6%
1/64 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
8.9%
7/79 • Number of events 8
|
7.8%
5/64 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.1%
4/79 • Number of events 5
|
0.00%
0/64
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
19.0%
15/79 • Number of events 16
|
17.2%
11/64 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
19.0%
15/79 • Number of events 15
|
14.1%
9/64 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
3.8%
3/79 • Number of events 4
|
7.8%
5/64 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
19.0%
15/79 • Number of events 17
|
15.6%
10/64 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
RASH
|
17.7%
14/79 • Number of events 15
|
25.0%
16/64 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
11.4%
9/79 • Number of events 12
|
4.7%
3/64 • Number of events 3
|
Additional Information
Senior Vice Predsident, 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