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

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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.

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
We found this trial at
7
sites
San Antonio, Texas 78215
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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Dallas, Texas 75203
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Marietta, GA
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Novi, Michigan 48377
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Novi, MI
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299 Avenida José de Diego
Santurce, 00909
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Santurce,
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