Hepatitis CPhase 1NCT00728936
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
A Phase 1 study testing IMO-2125 in people with Hepatitis C, run by Idera Pharmaceuticals, Inc. at 7 sites in 2 countries.
Trial summary
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- IMO-2125
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2007to May 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV-positive
- Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
University of Colorado Hospital
Aurora, Colorado, 80045
The Liver Institute
Dallas, Texas, 75203
Duke University Medical Center
Durham, North Carolina, 27705
Gastoenterstinal Specialist of Georgia, PA
Marietta, Georgia, 30060
Henry Ford Med Ctr- Columbus
Novi, Michigan, 48377
Alamo Medical Research
San Antonio, Texas, 78215
About this study
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
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- IMO-2125, Saline placebo
- Keywords
- Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMO-2125Drug
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
Saline placeboDrug
saline placebo given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| IMO-2125 0.04 mg/kg q week | Experimental | IMO-2125 given weekly at 0.04 mg/kg Receives: Drug: IMO-2125 |
| IMO-2125 0.08 mg/kg q week | Experimental | IMO-2125 given weekly at 0.08 mg/kg Receives: Drug: IMO-2125 |
| IMO-2125 0.16 mg/kg q week | Experimental | IMO-2125 given weekly at 0.16 mg/kg Receives: Drug: IMO-2125 |
| IMO-2125 0.32 mg/kg q week | Experimental | IMO-2125 given weekly at 0.32 mg/kg Receives: Drug: IMO-2125 |
| IMO-2125 0.48 mg/kg q week | Experimental | IMO-2125 given weekly at 0.48 mg/kg Receives: Drug: IMO-2125 |
| Placebo | Placebo comparator | Weekly saline placebo Receives: Drug: Saline placebo |
| IMO-2125 0.16 mg/kg twice a week | Experimental | IMO-2125 given twice a week at 0.16 mg/kg Receives: Drug: IMO-2125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety.
Count and percentage of subjects with treatment emergent adverse events
Measured: From screening through study completion, 86 to 115 days in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idera Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alice Bexon, MD, Study director, Idera Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728936
- Sponsor's protocol ID
- IMO-2125-001
- Status last verified
- Nov 2017
- First submitted
- 1 Aug 2008
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00728936
- Acronym / sponsor ID
- IMO-2125-001
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Idera Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Aug 2008 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IMO-2125 0.04 mg/kg q week | Experimental | Drug: IMO-2125IMO-2125 given weekly at 0.04 mg/kg |
| IMO-2125 0.08 mg/kg q week | Experimental | Drug: IMO-2125IMO-2125 given weekly at 0.08 mg/kg |
| IMO-2125 0.16 mg/kg q week | Experimental | Drug: IMO-2125IMO-2125 given weekly at 0.16 mg/kg |
| IMO-2125 0.32 mg/kg q week | Experimental | Drug: IMO-2125IMO-2125 given weekly at 0.32 mg/kg |
| IMO-2125 0.48 mg/kg q week | Experimental | Drug: IMO-2125IMO-2125 given weekly at 0.48 mg/kg |
| Placebo | Placebo comparator | Drug: Saline placeboWeekly saline placebo |
| IMO-2125 0.16 mg/kg twice a week | Experimental | Drug: IMO-2125IMO-2125 given twice a week at 0.16 mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HCV-positive
- Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMO-2125IMO-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 | Drug | 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 0.16 mg/kg twice a week, IMO-2125 0.32 mg/kg q week, IMO-2125 0.48 mg/kg q week |
| Saline placebosaline placebo given subcutaneously | Drug | Placebo |
Primary outcome
Evaluation of Safety.
Time frame: From screening through study completion, 86 to 115 days in total
Count and percentage of subjects with treatment emergent adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Bexon, MD study director
Idera Pharmaceuticals
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMO-2125 in people with Hepatitis C, run by Idera Pharmaceuticals, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety. (time frame: From screening through study completion, 86 to 115 days in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.