Trial Outcomes & Findings for RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness (NCT NCT00632463)
NCT ID: NCT00632463
Last Updated: 2013-04-24
Results Overview
The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Study day 18
Results posted on
2013-04-24
Participant Flow
Patient recruitment period took place between 06Jun2008 and 05Mar2010. Patient recruitment took place in hospitals.
Participant milestones
| Measure |
1 (High Dose)
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
1 (High Dose)
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Baseline characteristics by cohort
| Measure |
1 (High Dose)
n=7 Participants
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 Participants
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 Participants
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age Continuous
|
37 years
STANDARD_DEVIATION 29.06 • n=5 Participants
|
33 years
STANDARD_DEVIATION 23.25 • n=7 Participants
|
44.14 years
STANDARD_DEVIATION 25.06 • n=5 Participants
|
38.04 years
STANDARD_DEVIATION 25.03 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study day 18The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.
Outcome measures
| Measure |
1 (High Dose)
n=7 Participants
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 Participants
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 Participants
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Circulating RI-001 Titer
|
9.24 Fold Change
Interval 4.07 to 21.02
|
4.85 Fold Change
Interval 2.22 to 10.59
|
1.42 Fold Change
Interval 0.64 to 3.17
|
SECONDARY outcome
Timeframe: Study day 33Outcome measures
| Measure |
1 (High Dose)
n=7 Participants
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 Participants
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 Participants
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 DaysOutcome measures
| Measure |
1 (High Dose)
n=7 Participants
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 Participants
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 Participants
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
|
6 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
1 (High Dose)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
2 (Low Dose)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
3 (Placebo)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 (High Dose)
n=7 participants at risk
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 participants at risk
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 participants at risk
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Lower respiratory tract infection
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
Other adverse events
| Measure |
1 (High Dose)
n=7 participants at risk
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
2 (Low Dose)
n=7 participants at risk
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
|
3 (Placebo)
n=7 participants at risk
Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/7
|
|
Nervous system disorders
Dysguesia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Pyrexia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/7
|
28.6%
2/7 • Number of events 2
|
0.00%
0/7
|
|
Investigations
Blood albumin decreased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood potassium decreased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Heart rate increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal stiffness
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/7
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/7
|
|
Psychiatric disorders
Delirium
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Chest Pain
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Crepitations
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER