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Trial record 53 of 2126 for:    Hepatitis C

Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00728936
Recruitment Status : Completed
First Posted : August 6, 2008
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: IMO-2125
Drug: Saline placebo
Enrollment 58
Recruitment Details The study enrolled patients with chronic infection with hepatitis C virus (HCV) who were “null responders” to prior treatment with pegylated-interferon-alfa (peg-IFN-α) plus ribavirin. The study included patients with any HCV genotype.
Pre-assignment Details All enrolled subjects who qualified after the pre-screening period were assigned to a treatment group and treated.
Arm/Group Title Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Hide Arm/Group Description

Weekly saline placebo

Saline placebo: saline placebo given subcutaneously

IMO-2125 given weekly at 0.04 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.08 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.32 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.48 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given twice a week at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

Period Title: Overall Study
Started 10 8 9 8 8 8 7
Completed 10 8 9 8 8 7 7
Not Completed 0 0 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1             0
Arm/Group Title Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week Total
Hide Arm/Group Description

Weekly saline placebo

Saline placebo: saline placebo given subcutaneously

IMO-2125 given weekly at 0.04 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.08 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.32 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.48 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given twice a week at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

Total of all reporting groups
Overall Number of Baseline Participants 10 8 9 8 8 8 7 58
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants 58 participants
50
(43 to 57)
55
(45 to 59)
51
(30 to 61)
55.5
(50 to 65)
49
(42 to 55)
52.5
(35 to 58)
56
(19 to 63)
54
(30 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants 58 participants
Female
6
  60.0%
4
  50.0%
2
  22.2%
1
  12.5%
1
  12.5%
0
   0.0%
1
  14.3%
15
  25.9%
Male
4
  40.0%
4
  50.0%
7
  77.8%
7
  87.5%
7
  87.5%
8
 100.0%
6
  85.7%
43
  74.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
1
  12.5%
0
   0.0%
4
  50.0%
2
  25.0%
2
  25.0%
0
   0.0%
11
  19.0%
White
8
  80.0%
7
  87.5%
9
 100.0%
4
  50.0%
6
  75.0%
6
  75.0%
6
  85.7%
46
  79.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 9 participants 8 participants 8 participants 8 participants 7 participants 58 participants
1a 7 4 6 6 4 7 4 38
1b 3 3 3 2 4 1 3 19
4a or 4c or 4d 0 1 0 0 0 0 0 1
1.Primary Outcome
Title Evaluation of Safety.
Hide Description Count and percentage of subjects with treatment emergent adverse events
Time Frame From screening through study completion, 86 to 115 days in total
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Hide Arm/Group Description:

Weekly saline placebo

Saline placebo: saline placebo given subcutaneously

IMO-2125 given weekly at 0.04 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.08 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.32 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.48 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given twice a week at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

Overall Number of Participants Analyzed 10 8 9 8 8 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 TEAE
6
  60.0%
8
 100.0%
9
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
7
 100.0%
Study drug-related TEAE
5
  50.0%
7
  87.5%
9
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
7
 100.0%
TEAE leading to study drug discontinuation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
Related TEAE causing study drug discontinuation
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serious Adverse Events
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
Time Frame From screening through study completion, 86 to 115 days in total
Adverse Event Reporting Description Any untoward medical occurrence in a clinical investigation patient administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An Adverse Event can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
 
Arm/Group Title Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Hide Arm/Group Description

Weekly saline placebo

Saline placebo: saline placebo given subcutaneously

IMO-2125 given weekly at 0.04 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.08 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.32 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given weekly at 0.48 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 given twice a week at 0.16 mg/kg

IMO-2125: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

All-Cause Mortality
Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/9 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/9 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   1/8 (12.50%)   0/7 (0.00%) 
Gastrointestinal disorders               
Erosive esophaghitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo IMO-2125 0.04 mg/kg q Week IMO-2125 0.08 mg/kg q Week IMO-2125 0.16 mg/kg q Week IMO-2125 0.32 mg/kg q Week IMO-2125 0.48 mg/kg q Week IMO-2125 0.16 mg/kg Twice a Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/10 (60.00%)   8/8 (100.00%)   9/9 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders               
Lymphopenia * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/7 (0.00%) 
Neutropenia * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%) 
Cardiac disorders               
Palpitations * 1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Ear and labyrinth disorders               
Ear pain * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/7 (28.57%) 
Tinnitus * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Eye disorders               
Conjunctivitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/7 (28.57%) 
Dry eye * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Eyelid irritation * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%) 
Gastrointestinal disorders               
Abdominal discomfort * 1  1/10 (10.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Constipation * 1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Diarrhea * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Dyspepsia * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%) 
Gastric mucosal lesion * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Gastroesophageal reflux disease * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Hiatis hernia * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Hypoasethsia oral * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Nausea * 1  2/10 (20.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  3/7 (42.86%) 
Tongue ulceration * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%) 
Vomiting * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/7 (0.00%) 
General disorders               
Chills * 1  0/10 (0.00%)  0/8 (0.00%)  2/9 (22.22%)  2/8 (25.00%)  3/8 (37.50%)  2/8 (25.00%)  1/7 (14.29%) 
Fatigue * 1  1/10 (10.00%)  3/8 (37.50%)  1/9 (11.11%)  2/8 (25.00%)  2/8 (25.00%)  1/8 (12.50%)  2/7 (28.57%) 
Influenza-like illness * 1  2/10 (20.00%)  5/8 (62.50%)  5/9 (55.56%)  4/8 (50.00%)  4/8 (50.00%)  7/8 (87.50%)  5/7 (71.43%) 
Injection site dermatitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Injection site erythema * 1  1/10 (10.00%)  5/8 (62.50%)  9/9 (100.00%)  8/8 (100.00%)  8/8 (100.00%)  8/8 (100.00%)  7/7 (100.00%) 
Injection site hematoma * 1  1/10 (10.00%)  0/8 (0.00%)  1/9 (11.11%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  3/7 (42.86%) 
Injection site hemorrhage * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/7 (0.00%) 
Injection site induration * 1  1/10 (10.00%)  5/8 (62.50%)  6/9 (66.67%)  4/8 (50.00%)  7/8 (87.50%)  7/8 (87.50%)  6/7 (85.71%) 
Injection site edema * 1  1/10 (10.00%)  1/8 (12.50%)  3/9 (33.33%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/7 (0.00%) 
Injection site pain * 1  1/10 (10.00%)  1/8 (12.50%)  2/9 (22.22%)  4/8 (50.00%)  3/8 (37.50%)  5/8 (62.50%)  6/7 (85.71%) 
Injection site paraesthesia * 1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Injection site pruritis * 1  1/10 (10.00%)  4/8 (50.00%)  1/9 (11.11%)  2/8 (25.00%)  4/8 (50.00%)  2/8 (25.00%)  2/7 (28.57%) 
Injection site rash * 1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Injection site warmth * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  4/7 (57.14%) 
Edema peripheral * 1  1/10 (10.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  4/8 (50.00%)  1/8 (12.50%)  0/7 (0.00%) 
Pyrexia * 1  1/10 (10.00%)  1/8 (12.50%)  0/9 (0.00%)  1/8 (12.50%)  4/8 (50.00%)  1/8 (12.50%)  0/7 (0.00%) 
Infections and infestations               
Injection site cellulitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Otitis media * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%) 
Upper respiratory tract infection * 1  1/10 (10.00%)  0/8 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Bronchitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Cellulitis * 1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%) 
Nasopharyngitis * 1  1/10 (10.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  1/10 (10.00%)  3/8 (37.50%)  1/9 (11.11%)  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  1/7 (14.29%) 
Myalgia * 1  2/10 (20.00%)  2/8 (25.00%)  1/9 (11.11%)  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  1/7 (14.29%) 
Nervous system disorders               
Headache * 1  2/10 (20.00%)  2/8 (25.00%)  0/9 (0.00%)  4/8 (50.00%)  5/8 (62.50%)  2/8 (25.00%)  3/7 (42.86%) 
Vascular disorders               
Hypertension * 1  1/10 (10.00%)  0/8 (0.00%)  1/9 (11.11%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Idera Medical Monitor
Organization: Idera Pharmaceuticals, Inc
Phone: 617-679-5500
Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00728936     History of Changes
Other Study ID Numbers: IMO-2125-001
First Submitted: August 1, 2008
First Posted: August 6, 2008
Results First Submitted: November 28, 2017
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019