Trial Outcomes & Findings for Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment (NCT NCT01585584)
NCT ID: NCT01585584
Last Updated: 2015-09-21
Results Overview
Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
24 weeks after treatment
Results posted on
2015-09-21
Participant Flow
It was hoped that 21 patients with chronic HCV genotype 3 who had failed to achieve an SVR with a standard course of treatment with Peginterferon α + ribavirin (PR) would be selected from the University of Calgary Liver Unit (UCLU) database. 11 patients were able to be enrolled in the study.The last patient completed the study in December 2014.
Of the 11 patients who were enrolled in the study, 1 patient was a screen failure.
Participant milestones
| Measure |
Victrelis Triple
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Victrelis Triple
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Baseline characteristics by cohort
| Measure |
Victrelis Triple
n=10 Participants
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 6.945 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after treatmentPopulation: Patients who completed full course of treatment
Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
Outcome measures
| Measure |
Victrelis Triple
n=6 Participants
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
Subjects who completed treatment
|
6 participants
|
|
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
Subjects who obtained SVR 24
|
3 participants
|
Adverse Events
Victrelis Triple
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Victrelis Triple
n=10 participants at risk
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
Infections and infestations
Emergency room visit due to suspected celulitis
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Pregnancy in spouse
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
Victrelis Triple
n=10 participants at risk
All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
|
|---|---|
|
General disorders
Abdominal pain
|
30.0%
3/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
3/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Anisocytosis
|
10.0%
1/10 • 52 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
6/10 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Apthous ulcers
|
20.0%
2/10 • 52 weeks
|
|
Eye disorders
Blurred vision
|
30.0%
3/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
10.0%
1/10 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
20.0%
2/10 • 52 weeks
|
|
General disorders
Chills
|
80.0%
8/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain on inspiration
|
10.0%
1/10 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Delayed healing
|
30.0%
3/10 • 52 weeks
|
|
Psychiatric disorders
Despressed mood
|
10.0%
1/10 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • 52 weeks
|
|
Psychiatric disorders
Difficulty concentrating
|
20.0%
2/10 • 52 weeks
|
|
Renal and urinary disorders
Diuresis
|
30.0%
3/10 • 52 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
50.0%
5/10 • 52 weeks
|
|
General disorders
Dry mouth
|
60.0%
6/10 • 52 weeks
|
|
General disorders
Dry nose
|
10.0%
1/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.0%
6/10 • 52 weeks
|
|
Gastrointestinal disorders
Dysgeusia
|
80.0%
8/10 • 52 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Exerional dyspnea
|
40.0%
4/10 • 52 weeks
|
|
General disorders
Fatigue
|
80.0%
8/10 • 52 weeks
|
|
Psychiatric disorders
Feeling overwhlemed
|
10.0%
1/10 • 52 weeks
|
|
General disorders
Fever
|
70.0%
7/10 • 52 weeks
|
|
General disorders
Headache
|
70.0%
7/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Increased LDL
|
10.0%
1/10 • 52 weeks
|
|
General disorders
Hyperactivity
|
10.0%
1/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
20.0%
2/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hypertriglyceridemia
|
50.0%
5/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hypoalbuminema
|
40.0%
4/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hypochloremia
|
30.0%
3/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hypochromia
|
10.0%
1/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Hyponatremia
|
10.0%
1/10 • 52 weeks
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Increased INR
|
30.0%
3/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Increased leukocytes
|
10.0%
1/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Increased neutrophils
|
10.0%
1/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Local injection site reactions
|
90.0%
9/10 • 52 weeks
|
|
General disorders
Insomnia
|
100.0%
10/10 • 52 weeks
|
|
Psychiatric disorders
Irritability
|
40.0%
4/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
70.0%
7/10 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
60.0%
6/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
80.0%
8/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Low HDL
|
10.0%
1/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung congestion
|
10.0%
1/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
30.0%
3/10 • 52 weeks
|
|
Psychiatric disorders
Memory impairment
|
10.0%
1/10 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
90.0%
9/10 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
80.0%
8/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Non-productive cough
|
40.0%
4/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Nose bleed
|
30.0%
3/10 • 52 weeks
|
|
Nervous system disorders
Numbness/tingling
|
20.0%
2/10 • 52 weeks
|
|
Cardiac disorders
Orthostatic hypotension
|
20.0%
2/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Polychromasia
|
20.0%
2/10 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • 52 weeks
|
|
Immune system disorders
Worsening of psoriasis
|
20.0%
2/10 • 52 weeks
|
|
Ear and labyrinth disorders
Pulsatile tinnitus
|
20.0%
2/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
6/10 • 52 weeks
|
|
Nervous system disorders
Resltess legs
|
10.0%
1/10 • 52 weeks
|
|
General disorders
Sinus congestion
|
30.0%
3/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin tags
|
10.0%
1/10 • 52 weeks
|
|
Eye disorders
Irritated eyes
|
40.0%
4/10 • 52 weeks
|
|
General disorders
Peripheral edema
|
10.0%
1/10 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Tender gums
|
20.0%
2/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
8/10 • 52 weeks
|
|
Gastrointestinal disorders
Tongue discolouration
|
10.0%
1/10 • 52 weeks
|
|
Cardiac disorders
Transient heart rate increase
|
10.0%
1/10 • 52 weeks
|
|
Gastrointestinal disorders
Indigestion
|
50.0%
5/10 • 52 weeks
|
|
Vascular disorders
Vasculitis
|
10.0%
1/10 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
20.0%
2/10 • 52 weeks
|
|
General disorders
Weight loss
|
50.0%
5/10 • 52 weeks
|
|
Blood and lymphatic system disorders
Low LDL
|
10.0%
1/10 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place