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Completed

NCT Number: NCT00728936

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

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundacion de Investigacion de Diego, Santurce, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMO-2125

Drug

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 placebo

Drug

saline placebo given subcutaneously

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Idera Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 6, 2008
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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