Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Sponsor
Idera Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00728936
Collaborator
(none)
58
7
7
32
8.3
0.3
Study Details
Study Description
Brief Summary
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.
Study Design
Study Type:
Interventional
Actual Enrollment
:
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin
Study Start Date
:
Sep 1, 2007
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
May 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMO-2125 0.04 mg/kg q week IMO-2125 given weekly at 0.04 mg/kg |
Drug: 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
|
| Experimental: IMO-2125 0.08 mg/kg q week IMO-2125 given weekly at 0.08 mg/kg |
Drug: 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
|
| Experimental: IMO-2125 0.16 mg/kg q week IMO-2125 given weekly at 0.16 mg/kg |
Drug: 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
|
| Experimental: IMO-2125 0.32 mg/kg q week IMO-2125 given weekly at 0.32 mg/kg |
Drug: 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
|
| Experimental: IMO-2125 0.48 mg/kg q week IMO-2125 given weekly at 0.48 mg/kg |
Drug: 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
|
| Placebo Comparator: Placebo Weekly saline placebo |
Drug: Saline placebo
saline placebo given subcutaneously
|
| Experimental: IMO-2125 0.16 mg/kg twice a week IMO-2125 given twice a week at 0.16 mg/kg |
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- Evaluation of Safety. [From screening through study completion, 86 to 115 days in total]
Count and percentage of subjects with treatment emergent adverse events
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
HCV-positive
-
Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Exclusion Criteria:
-
Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
-
Inadequate bone marrow, liver, and renal function
-
Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
-
Other significant medical diseases
-
Known alcohol or drug abuse within the past 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 2 | Gastoenterstinal Specialist of Georgia, PA | Marietta | Georgia | United States | 30060 |
| 3 | Henry Ford Med Ctr- Columbus | Novi | Michigan | United States | 48377 |
| 4 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 5 | The Liver Institute | Dallas | Texas | United States | 75203 |
| 6 | Alamo Medical Research | San Antonio | Texas | United States | 78215 |
| 7 | Fundacion de Investigacion de Diego | Santurce | Puerto Rico | 00909 |
Sponsors and Collaborators
- Idera Pharmaceuticals, Inc.
Investigators
- Study Director: Alice Bexon, MD, Idera Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00728936
Other Study ID Numbers:
- IMO-2125-001
First Posted:
Aug 6, 2008
Last Update Posted:
Feb 15, 2019
Last Verified:
Nov 1, 2017
Keywords provided by Idera Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|---|---|---|
| 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 Participants | 10 | 8 | 9 | 8 | 8 | 8 | 7 | 58 |
| Age (years) [Median (Full Range) ] | ||||||||
| Median (Full Range) [years] |
50
|
55
|
51
|
55.5
|
49
|
52.5
|
56
|
54
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
6
60%
|
4
50%
|
2
22.2%
|
1
12.5%
|
1
12.5%
|
0
0%
|
1
14.3%
|
15
25.9%
|
| Male |
4
40%
|
4
50%
|
7
77.8%
|
7
87.5%
|
7
87.5%
|
8
100%
|
6
85.7%
|
43
74.1%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
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%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
20%
|
1
12.5%
|
0
0%
|
4
50%
|
2
25%
|
2
25%
|
0
0%
|
11
19%
|
| White |
8
80%
|
7
87.5%
|
9
100%
|
4
50%
|
6
75%
|
6
75%
|
6
85.7%
|
46
79.3%
|
| More than one race |
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%
|
| HCV Genotype (Count of Participants) | ||||||||
| 1a |
7
70%
|
4
50%
|
6
66.7%
|
6
75%
|
4
50%
|
7
87.5%
|
4
57.1%
|
38
65.5%
|
| 1b |
3
30%
|
3
37.5%
|
3
33.3%
|
2
25%
|
4
50%
|
1
12.5%
|
3
42.9%
|
19
32.8%
|
| 4a or 4c or 4d |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.7%
|
Outcome Measures
| Title | Evaluation of Safety. |
|---|---|
| Description | Count and percentage of subjects with treatment emergent adverse events |
| Time Frame | From screening through study completion, 86 to 115 days in total |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
| Measure Participants | 10 | 8 | 9 | 8 | 8 | 8 | 7 |
| At least 1 TEAE |
6
60%
|
8
100%
|
9
100%
|
8
100%
|
8
100%
|
8
100%
|
7
100%
|
| Study drug-related TEAE |
5
50%
|
7
87.5%
|
9
100%
|
8
100%
|
8
100%
|
8
100%
|
7
100%
|
| TEAE leading to study drug discontinuation |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
| Related TEAE causing study drug discontinuation |
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%
|
1
12.5%
|
0
0%
|
Adverse Events
| 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 | |||||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Erosive esophaghitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/10 (60%) | 8/8 (100%) | 9/9 (100%) | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | 7/7 (100%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Lymphopenia | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) | 0/7 (0%) | |||||||
| Neutropenia | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Cardiac disorders | ||||||||||||||
| Palpitations | 0/10 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Ear pain | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 2/7 (28.6%) | |||||||
| Tinnitus | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Conjunctivitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 2/7 (28.6%) | |||||||
| Dry eye | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Eyelid irritation | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/7 (14.3%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal discomfort | 1/10 (10%) | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Constipation | 0/10 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Diarrhea | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Dyspepsia | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/7 (14.3%) | |||||||
| Gastric mucosal lesion | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Gastroesophageal reflux disease | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Hiatis hernia | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Hypoasethsia oral | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Nausea | 2/10 (20%) | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 2/8 (25%) | 2/8 (25%) | 3/7 (42.9%) | |||||||
| Tongue ulceration | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Vomiting | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 1/8 (12.5%) | 2/8 (25%) | 0/7 (0%) | |||||||
| General disorders | ||||||||||||||
| Chills | 0/10 (0%) | 0/8 (0%) | 2/9 (22.2%) | 2/8 (25%) | 3/8 (37.5%) | 2/8 (25%) | 1/7 (14.3%) | |||||||
| Fatigue | 1/10 (10%) | 3/8 (37.5%) | 1/9 (11.1%) | 2/8 (25%) | 2/8 (25%) | 1/8 (12.5%) | 2/7 (28.6%) | |||||||
| Influenza-like illness | 2/10 (20%) | 5/8 (62.5%) | 5/9 (55.6%) | 4/8 (50%) | 4/8 (50%) | 7/8 (87.5%) | 5/7 (71.4%) | |||||||
| Injection site dermatitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Injection site erythema | 1/10 (10%) | 5/8 (62.5%) | 9/9 (100%) | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | 7/7 (100%) | |||||||
| Injection site hematoma | 1/10 (10%) | 0/8 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 3/7 (42.9%) | |||||||
| Injection site hemorrhage | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) | 0/7 (0%) | |||||||
| Injection site induration | 1/10 (10%) | 5/8 (62.5%) | 6/9 (66.7%) | 4/8 (50%) | 7/8 (87.5%) | 7/8 (87.5%) | 6/7 (85.7%) | |||||||
| Injection site edema | 1/10 (10%) | 1/8 (12.5%) | 3/9 (33.3%) | 0/8 (0%) | 1/8 (12.5%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Injection site pain | 1/10 (10%) | 1/8 (12.5%) | 2/9 (22.2%) | 4/8 (50%) | 3/8 (37.5%) | 5/8 (62.5%) | 6/7 (85.7%) | |||||||
| Injection site paraesthesia | 1/10 (10%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Injection site pruritis | 1/10 (10%) | 4/8 (50%) | 1/9 (11.1%) | 2/8 (25%) | 4/8 (50%) | 2/8 (25%) | 2/7 (28.6%) | |||||||
| Injection site rash | 0/10 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Injection site warmth | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 3/8 (37.5%) | 0/8 (0%) | 4/7 (57.1%) | |||||||
| Edema peripheral | 1/10 (10%) | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 4/8 (50%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Pyrexia | 1/10 (10%) | 1/8 (12.5%) | 0/9 (0%) | 1/8 (12.5%) | 4/8 (50%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Injection site cellulitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 2/8 (25%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Otitis media | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 1/7 (14.3%) | |||||||
| Upper respiratory tract infection | 1/10 (10%) | 0/8 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Bronchitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Cellulitis | 0/10 (0%) | 0/8 (0%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) | 0/7 (0%) | |||||||
| Nasopharyngitis | 1/10 (10%) | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite | 0/10 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/8 (0%) | 2/8 (25%) | 0/8 (0%) | 0/7 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 1/10 (10%) | 3/8 (37.5%) | 1/9 (11.1%) | 1/8 (12.5%) | 2/8 (25%) | 0/8 (0%) | 1/7 (14.3%) | |||||||
| Myalgia | 2/10 (20%) | 2/8 (25%) | 1/9 (11.1%) | 2/8 (25%) | 2/8 (25%) | 0/8 (0%) | 1/7 (14.3%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 2/10 (20%) | 2/8 (25%) | 0/9 (0%) | 4/8 (50%) | 5/8 (62.5%) | 2/8 (25%) | 3/7 (42.9%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertension | 1/10 (10%) | 0/8 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/8 (0%) | 0/8 (0%) | 0/7 (0%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
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 |
| clinicaltrials@iderapharma.com |
Responsible Party:
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00728936
Other Study ID Numbers:
- IMO-2125-001
First Posted:
Aug 6, 2008
Last Update Posted:
Feb 15, 2019
Last Verified:
Nov 1, 2017