Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/17/2019 |
Start Date: | September 2007 |
End Date: | May 2010 |
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.
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.
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.
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
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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