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RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

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ClinicalTrials.gov Identifier: NCT00632463
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
ADMA Biologics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
Intervention Biological: RI-001
Enrollment 21
Recruitment Details Patient recruitment period took place between 06Jun2008 and 05Mar2010. Patient recruitment took place in hospitals.
Pre-assignment Details  
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo)
Hide Arm/Group Description Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3. Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3. Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
Period Title: Overall Study
Started 7 7 7
Completed 7 6 7
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo) Total
Hide Arm/Group Description Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3. Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3. 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 of all reporting groups
Overall Number of Baseline Participants 7 7 7 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 21 participants
<=18 years
3
  42.9%
2
  28.6%
2
  28.6%
7
  33.3%
Between 18 and 65 years
3
  42.9%
5
  71.4%
4
  57.1%
12
  57.1%
>=65 years
1
  14.3%
0
   0.0%
1
  14.3%
2
   9.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 7 participants 21 participants
37  (29.06) 33  (23.25) 44.14  (25.06) 38.04  (25.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 21 participants
Female
5
  71.4%
5
  71.4%
3
  42.9%
13
  61.9%
Male
2
  28.6%
2
  28.6%
4
  57.1%
8
  38.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 21 participants
United States 7 4 6 17
Canada 0 2 0 2
Australia 0 1 0 1
New Zealand 0 0 1 1
1.Primary Outcome
Title Circulating RI-001 Titer
Hide Description 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.
Time Frame Study day 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo)
Hide Arm/Group Description:
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
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 Number of Participants Analyzed 7 7 7
Mean (95% Confidence Interval)
Unit of Measure: Fold Change
9.24
(4.07 to 21.02)
4.85
(2.22 to 10.59)
1.42
(0.64 to 3.17)
2.Secondary Outcome
Title Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
Hide Description [Not Specified]
Time Frame Study day 33
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo)
Hide Arm/Group Description:
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
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 Number of Participants Analyzed 7 7 7
Measure Type: Number
Unit of Measure: Participants
1 2 1
3.Secondary Outcome
Title The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
Hide Description [Not Specified]
Time Frame 18 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo)
Hide Arm/Group Description:
Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3.
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 Number of Participants Analyzed 7 7 7
Measure Type: Number
Unit of Measure: Participants
6 3 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 (High Dose) 2 (Low Dose) 3 (Placebo)
Hide Arm/Group Description Dose regimen 1 (High Dose): RI-001 1,500 mg/kg dose on day 1, and 750 mg/kg dose on day 3. Dose regimen 2 (Low Dose): RI-001 750 mg/kg dose on day 1, and 750 mg/kg dose on day 3. Placebo (Normal saline): 7.5 mL/kg or 15 mL/kg dose on day 1, and 7.5 mL/kg dose on day 2.
All-Cause Mortality
1 (High Dose) 2 (Low Dose) 3 (Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
1 (High Dose) 2 (Low Dose) 3 (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      4/7 (57.14%)      1/7 (14.29%)    
Blood and lymphatic system disorders       
Lymphadenopathy * 2  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Neutropenia * 2  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea * 2  0/7 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0
General disorders       
Pyrexia * 2  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations       
Pneumonia * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Lower respiratory tract infection * 2  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Pneumonia respiratory syncytial viral * 2  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Pneumonia streptococcal * 2  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Post transplant lymphoproliferative disorder * 2  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders       
Altered state of consciousness * 2  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Syncope * 2  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonitis * 2  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 (High Dose) 2 (Low Dose) 3 (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/7 (57.14%)      6/7 (85.71%)      4/7 (57.14%)    
Blood and lymphatic system disorders       
Anaemia * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Cardiac disorders       
Tachycardia * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Eye disorders       
Eyelid ptosis * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  1/7 (14.29%)  1 1/7 (14.29%)  1 1/7 (14.29%)  1
Diarrhoea * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Constipation * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Gastroesophageal reflux disease * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Vomiting * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Dry mouth * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
General disorders       
Pyrexia * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Chills * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Chest Pain * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Crepitations * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Immune system disorders       
Graft versus host disease * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Hypersensitivity * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Infections and infestations       
Sinusitis * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Investigations       
Platelet count decreased * 1  0/7 (0.00%)  0 2/7 (28.57%)  2 0/7 (0.00%)  0
Blood albumin decreased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Blood lactate dehydrogenase increased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Blood magnesium decreased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Blood phosphorus decreased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Blood potassium decreased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Haemoglobin decreased * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Heart rate increased * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Breath sounds abnormal * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/7 (14.29%)  1 1/7 (14.29%)  1 0/7 (0.00%)  0
musculoskeletal stiffness * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Nervous system disorders       
Dysguesia * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Somnolence * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Headache * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Paraesthesia * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Psychiatric disorders       
Delirium * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Panic Attack * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Renal and urinary disorders       
Polyuria * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Renal failure * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/7 (14.29%)  1 1/7 (14.29%)  1 2/7 (28.57%)  4
Sinus Congestion * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 1/7 (14.29%)  1
Dyspnoea * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Nasal Congestion * 1  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0
Tachypnoea * 1  1/7 (14.29%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Throat irritation * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Productive cough * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 1/7 (14.29%)  1
Epistaxis * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Pharyngolaryngeal pain * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders       
Erythema * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Vascular disorders       
Hypertension * 1  1/7 (14.29%)  2 0/7 (0.00%)  0 0/7 (0.00%)  0
Labile blood pressure * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Orthostatic hypotension * 1  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0
Flushing * 1  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Unfortunately enrollment in this study was suspended early due to slow accrual rates.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: ADMA Biologics
Phone: 201-478-5552
EMail: agrossman@admabio.com
Layout table for additonal information
Responsible Party: ADMA Biologics, Inc.
ClinicalTrials.gov Identifier: NCT00632463    
Other Study ID Numbers: ADMA-001
First Submitted: March 3, 2008
First Posted: March 10, 2008
Results First Submitted: February 22, 2013
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013